DreamStation DreamStation Heated Humidifier, Core Pack, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00606959022652), received between Dec 19, 2017 and Nov 11, 2025 — classified as 9 deaths, 135 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Degraded” (241 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 262 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Contamination; Degraded; Fire; Sparking; Contamination; Degraded; Fire; Sparking

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAM STATION HUMID. THE MANUFACTURER RECEIVED INFORMATION THAT ALLEGING THAT THE DEVICE SPARKED AND CAUSED THE CERAMIC PLATE TO BURN. ADDITIONALLY, DURING THE INCIDENT, THE CUSTOMER EXPERIENCED AN ELECTRIC SHOCK, AND FLAMES WERE SEEN COMING FROM THE UNIT, WHICH SUBSEQUENTLY CAUGHT ON FIRE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION OF DEVICE, AN UNKNOWN CONTAMINANT WAS OBSERVED ON THE TOP ENCLOSURE, FRONT PANEL, BOTTOM ENCLOSURE, ON THE BLOWER, INSIDE THE BLOWER, BLOWER BOX, AND ON THE BLOWER SEAL. EVIDENCE OF LIQUID INGRESS WAS OBSERVED ON THE BLOWER AND BLOWER BOX. KERATIN- LIKE SUBSTANCE WAS OBSERVED AROUND THE BLOWER BOX OUTLET. EVIDENCE OF SOUND FOAM DEGRADATION/BREAKDOWN WAS OBSERVED. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520787 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAM STATION HUMID. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING HEADACHES AND EXTREME NASAL CONGESTION. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED PIL IS UNABLE DIRECTLY ADDRESS THE SYMPTOMS OUTLINED IN THE COMPLAINT. OBSERVED MINOR STAINS AND CONTAMINATION ON EXTERIOR OF DEVICE AND INTERIOR OF HUMIDIFIER CHAMBER. CONTAMINATION WAS OBSERVED IN THE INTERIOR OF THE HUMIDIFIER BOTTOM PLATE. UNKNOWN CONTAMINATION WAS EVIDENT AROUND THE SEAL AREA OF THE HEATER PLATE. PRESENCE OF UNKNOWN CONTAMINATION ON EXTERIOR OF DRY BOX. PRESENCE OF UNKNOWN CONTAMINATION FOUND INSIDE THE FLIP LIP SEAL. ONE ARM OF THE HUMIDIFIER LATCH SPRING WAS BROKEN, EVIDENCE OF LIQUID INGRESS OBSERVED ON BLOWER, CRACKS WERE EVIDENT IN THE AREA OF THE WATER TANK HEATER PAN SECONDARY FINDINGS WERE NOT OBSERVED AND T

  Patient problems: Headache; Nasal congestion

  MAUDE report 23520739 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAM STATION HUMID. THE MANUFACTURER RECEIVED INFORMATION ALLEGING EXPERIENCING SORE THROAT AND NOSE, SINUS CONGESTION, HEADACHES, DIZZINESS, DIFFICULTY BREATHING. PATIENT ALLEGEDLY STATES A FOUL ODOR. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED DUST/DIRT CONTAMINATION ON TOP AND BOTTOM ENCLOSURES, UI PANEL, REAR PANEL, SD COVER FLIP DOOR, CONTROL DIAL, KEYPAD, PCA, BLOWER BOX UPPER CAP, BLOWER, BLOWER BOX, BLOWER OUTLET SEAL, P4 POWER CONNECTOR, DC JACK COLOR INSERT, WATER TANK, FLIP LID ASSEMBLY, HUMIDIFIER BOTTOM ENCLOSURE, FLIP LID SEAL, LIFTING TRAY, DRY BOX SEAL, HUMIDIFIER REAR PANEL. MISSING ACCESSORY MODULE FLIP DOOR. PIL TECHNICIAN OBSERVED NO ODOR COMING FROM THE DEVICE. UNKNOWN CONTAMINATE WAS OBSERVED INSIDE THE UI PANEL. AN INSECT W

  Patient problems: Dizziness; Dyspnea; Headache; Sinusitis; Sore Throat; Unspecified Respiratory Problem

  MAUDE report 23520485 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING HEADACHES AND SORE THROAT RELATED TO A DREAMSTATION HUMID. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED THE DUST/DIRT CONTAMINATION FOUND AT THE AIR INLET, ISO PORT, ON THE FRONT AND BACK PANEL, MOTOR CASING/IMPELLERS, AND BLOWER BOX WAS INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM CONTAMINATION. THE PRESENCE OF CONTAMINATION THROUGHOUT THE AIRPATH, SUGGESTS A SOURCE EXTERNAL TO THE DEVICE. MINERAL SPOTS CONSISTENT WITH WATER INGRESS WERE FOUND ON THE BLOWER BOX AND MOTOR CASING. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX APPEARS CONSISTENT WITH THE KERATIN CONTAMINATION. THE DUST/DIRT CONTAMINATION FOUND WITHIN THE HUMIDIFIER UNIT, ON THE ISO PORT, WITHIN THE DRY BOX AND DRY BOX ASSEMBLY, ON THE DRY BOX SEAL, AND ON THE EDGE OF THE HEATER PLATE. MINERAL SPOTS CONSISTENT WITH T

  Patient problems: Headache; Sore Throat

  MAUDE report 23520484 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAM STATION HUMID. THE MANUFACTURER RECEIVED INFORMATION ALLEGING HAVING SEVERE SINUS CONGESTION, SEVERE DRY EYES, AND A STRANGE ODOR FROM THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED DUST/DIRT CONTAMINATION ON TOP AND BOTTOM ENCLOSURES, UI PANEL, REAR PANEL, SD COVER FLIP DOOR, ACCESSORY MODULE FLIP DOOR, CONTROL DIAL, KEYPAD, BLOWER, BLOWER BOX, BLOWER OUTLET SEAL, P4 POWER CONNECTOR, FLIP LID ASSEMBLY, HUMIDIFIER BOTTOM ENCLOSURE, FLIP LID SEAL, HEATER PLATE, LIFTING TRAY, DRY BOX SEAL, DRY BOX, HUMIDIFIER REAR PANEL. MOLD LIKE BACTERIA WAS OBSERVED ON THE FLIP LID SEAL. DISCOLORATION WAS OBSERVED ON THE FLIP LID SEAL AND DRY BOX SEAL. THE MODEM WAS UNABLE TO CONNECT TO THE ERROR LOG VIEWER. LIQUID INGRESS WAS OBSERVED ON THE BLOWE

  Patient problems: Dry Eye(s); Sinusitis

  MAUDE report 23520481 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  A DEVICE WAS RETURNED TO MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING HEADACHES, NAUSEA, THROAT IRRITATION/SORENESS, BAD COUGH, AND DIZZINESS. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, EXTERNAL INVESTIGATION OF THE DEVICE WAS PERFORMED, AND NO ISSUES WERE FOUND. THE MANUFACTURER CONFIRMED DEVICE POWERED UP, PROVIDED AIRFLOW, HEATER HEATS, AND HEATED TUBING HEATS. DURING INTERNAL INVESTIGATION, PIL OBSERVED AN UNKNOWN CONTAMINANT ON THE BLOWER BOX, UI PANEL, AND BOTTOM ENCLOSURE OF BASE UNIT. AN UNKNOWN CONTAMINANT WAS OBSERVED ON THE HUMIDIFIER BOTTOM ENCLOSURE, FLIP LID SEAL, LIFTING TRAY, DRY BOX SEAL, HEATER PLATE, AND HINGES BETWEEN FLIP LID/BOTTOM ASSEMBLY. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER F

  Patient problems: Cough; Dizziness; Headache; Nausea; No Clinical Signs, Symptoms or Conditions; Sore Throat

  MAUDE report 23520418 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Improper Chemical Reaction; Contamination; Degraded; Improper Chemical Reaction

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, MECHANICAL VENTILATOR DEVICE AND DREAMSTATION HUMID. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING DEVELOPED A SPOT ON HER LUNG. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE INSPECTED OBSERVED DUST/DIRT CONTAMINATION ON TOP AND BOTTOM ENCLOSURES, UI PANEL, REAR PANEL, SD COVER FLIP DOOR, CONTROL DIAL, KEYPAD, BLOWER, BLOWER BOX, BLOWER OUTLET SEAL, P4 POWER CONNECTOR, FLIP LID ASSEMBLY, BOTTOM ASSEMBLY, WATER TANK, LIFTING TRAY, DRY BOX SEAL, DRY BOX, FLIP LID SEAL. A RUST LIKE CONTAMINATE WAS OBSERVED ON THE WATER TANK PLATE. A HAIRLIKE SUBSTANCE WAS OBSERVED INSIDE THE BOTTOM ASSEMBLY. LIQUID INGRESS WAS OBSERVED ON THE P4 POWER CONNECTOR. INV1023 ADDRESSES THE ISSUE OF LIQUID INGRESS. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED S

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 23520353 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT HAS ALLEGED HEADACHES, NO POWER SUPPLY, TUBING OR MASK WAS SUPPLIED WITH THE DEVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER USING FITT (FOAM INTEGRITY TEST TOOL) TOOK PER FITT DOCUMENT TO TEST THE SOUND ABATEMENT FOAM FOR DEGRADATION AND BREAKDOWN. THE MANUFACTURER DID FIND EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION WHICH WAS OBSERVED IN THE BASE UNIT. THE MANUFACTURER CAN CONFIRM SOUND ABATEMENT FOAM DEGRADATION. DURING EVALUATION, SECONDARY FINDINGS DUST/DIRT CONTAMINATION ON THE FLIP LID LOCKING MECHANISM, OUTSIDE OF THE BLOWER BOX, OUTLET ISO PORT OF THE HUMIDIFIER, AND ON THE AIR INLET OF THE MOTOR WAS INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM CONTAMINATION AND CARE ORCHESTRATOR DATA AVAILABLE SUGGESTING THAT USER WAS 100% COMPLIANT WITH DEVICE USAGE. THE FOAM USING THE FITT TOOL, THE FOAM WAS DETERMINED TO BE DEGRADED. SLIGHT BLACK CONTAMINATION FOUND AT THE BLOWER SEAL OF THE BLOWER BOX, AND IT IS CONSISTENT WITH THE KERATIN CON

  Patient problems: Headache

  MAUDE report 23520352 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING WITH HEADACHE AND STATES FILTERS ARE DIRTY. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE EVALUATION PRESENCE OF SOUND ABATEMENT DEGRADATION WAS CONFIRMED USING A FITT (FOAM INTEGRITY TEST TOOL). EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THE BASE UNIT. SEE ER 2244873 (V1) FOR THE PROCEDURE USED TO MAKE THIS DETERMINATION. INITIATED THERAPY WHICH GENERATED AIRFLOW. DURING THE INVESTIGATION TECHNICIAN OBSERVED 0 ERRORS LOGGED. PIL RETRIEVED THE ERROR LOG. THERE WAS 1 INSTANCE OF REBOOT ERROR. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 (V1). FOR THE PURPOSES OF THIS INVESTIGATION, THIS ERROR WILL BE CONSIDERED IRRELEVANT. PIL CAN CONFIRM THE PRESENCE THE DUST/DIRT CONTAMINATION ON THE FLIP LID LOCKING MECHANISM, OUTSIDE OF

  Patient problems: Headache

  MAUDE report 23520350 ↗
• InjuryNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAMSTATION HUMID. THE MANUFACTURER RECEIVED HUMIDIFIER WITH A COMPLAINT OF CHRONIC KIDNEY DISEASE. NO OTHER PERIPHERALS OR ACCESSORIES WERE RETURNED WITH THE DEVICE. PATIENT STATED THAT SOCLEAN 2 WAS USED TWICE PER WEEK ON AVERAGE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS OBSERVED IN THIS DEVICE. PIL OBSERVED MULTIPLE UNKNOWN BROWN AND BLACK, CONTAMINANTS AND SOME SHORT BLACK HAIRS INSIDE OF HUMIDIFIER BOX AND ON DRY BOX SEAL. PIL OBSERVED A SMALL BROWN STAIN ON THE FLIP LID SEAL. PIL OBSERVED POTENTIAL BLACK WATER STAINS ON THE BOTTOM OF THE BACK PANEL AND ON THE BOTTOM OF THE HUMIDIFIER ENCLOSURE. PIL OBSERVED SLIGHT HEAT MARK ON THE HEATER PLATE. PIL OBSERVED A LARGE HEAT MARK ON THE PAN ON THE BOTTOM OF THE WATER TANK. THE CONTAMINATION FOUND IN THE HUMIDIFIER BOX ARE CONSIDERED NOT TO BE IN THE AIRPATH. THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE HUMIDIF

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 23520316 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING MOLDY RESIDUE IN THE TUBING AND WATER IN CHAMBER HAS BLACK RESIDUE. PATIENT'S SYMPTOM WAS CONGESTION IN THE MORNING. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER INSPECTED EXTERNALLY OBSERVED THAT HUMIDIFIER OUTSIDE BOTTOM OF ENCLOSURE HAD UNKNOWN BROWN STAINS ON IT. MULTIPLE UNKNOWN BROWN AND BLACK CONTAMINANTS, INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM, INSIDE OF HUMIDIFIER ENCLOSURE. STAINS OF POTENTIAL BIO-CONTAMINATES RESEMBLING BLACK MOLD AT THE BOTTOM OF THE HUMIDIFIER ENCLOSURE. MANY POTENTIAL TINY BLACK HAIRS OR FIBERS THROUGHOUT HUMIDIFIER ENCLOSURE BOTTOM AND A POTENTIAL LARGE HAIR OR FIBER. GREEN PIECE OF A POTENTIAL CONTAMINATION IN THE CORNER OF THE HUMIDIFIER ENCLOSURE BOTTOM. THE DRY BOX SEAL HAD POTENTIAL WHIT

  Patient problems: Nasal congestion

  MAUDE report 23520314 ↗
• InjuryNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGING DIFFICULTY BREATHING/SHORTNESS OF BREATH AND AN IRREGULAR HEARTBEAT. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED VISIBLE EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION AND BREAKDOWN IN THE BLOWER BOX, BLOWER, AND ISO PORT. SMALL AMOUNTS OF DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM FOUND THROUGHOUT DEVICE ENCLOSURE, OUTSIDE OF THE BLOWER BOX. EVIDENCE OF WATER INGRESS FOUND IN THE BOTTOM OF THE BLOWER BOX. CONTAMINATION CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM ON THE AIR OUTLET PORT AND THROUGHOUT THE AIRPATH. WHEN REMOVING THE SCREWS HOLDING THE BOTTOM COVER IN PLACE, ONE OF THE THREADS BROKE OFF WHERE A CORRODED SCREW WAS HOUSED. THE BROKEN THREAD AND SCREW WERE PLACED

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 23520312 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED POWER SUPPLY, POWER CORD TOO HOT TO TOUCH, HUMIDIFIER NOT WORKING, MACHINE DOESN'T TURN ON, HEADACHES, NAUSEA. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER USING A KNOWN GOOD POWER SUPPLY AND POWER CORD AND CONFIRMED THAT THE DEVICE POWERS ON AND PROVIDES THERAPY. A HEAT TEST WAS PERFORMED ON THE DEVICE, HEATER PLATE, AND PATIENT PORT TO VERIFY THAT THE TEMPERATURES WERE WITHIN THE REQUIRED PERIMETERS REQUIRED PER (B)(4) (V07)-HEATER PLATE, (B)(4) (V31)-POWER SUPPLY, AC POWER CORD, AND DC POWER CORD. MANUFACTURER TECH PERFORMED THIS TEST USING AN ASL-5000, A FLUKE THERMOMETER, A FLUKE MULTIMETER. THE TEST RESULTS SHOWED THAT THE HEATER PLATE DID NOT SHOW TEMPERATURES WITHIN THE THRESHOLD REQUIRED, POWER SUPPLY AND THE POWER CORD SHOWED TEMPERATURES WITHIN THE THRESHOLD REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S

  Patient problems: Headache; Nausea

  MAUDE report 23520281 ↗
• MalfunctionNov 11, 2025Contamination; Contamination

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAM STATION HUMID AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION WITH NO ALLEGATION. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE EVALUATION PRESENCE OF CONTAMINATION WAS CONFIRMED USING A FITT (FOAM INTEGRITY TEST TOOL). - PIL OBSERVED MINERAL DEPOSITS / CORROSION ON THE SCREWS AT THE BOTTOM OF THE HUMIDIFIER ENCLOSURE. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX AND IT IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN (B)(4) V1. DURING THE INVESTIGATION TECHNICIAN OBSERVED 0 ERRORS LOGGED. PIL OBSERVED DUST/DIRT CONTAMINATION IN THE DEVICE ENCLOSURE AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. PIL OBSERVED DUST / DIRT CONTAMINATION ON THE OUTER SURFACES, CRACKS, AND CREVICES. PIL LOCATED A LIGHT AMOUNT OF BEIGE DUST OR DUST CONTAMINANT AROUND THE OUTLET PORT. PIL CAN CONFIRM THE COMPLAINT THAT THE DEVICE WILL NOT TURN ON/DEVICE NOT FUNCTIONING, A FINAL TEST WAS RUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520279 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Device Emits Odor; Contamination; Degraded; Device Emits Odor

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAMSTATION HUMID. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING NASAL AND THROAT INFECTIONS. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE INSPECTED EXTERNALLY OBSERVED CONTAMINATION ON THE BOTTOM OF BASE AND HUMIDIFIER, BETWEEN THE UNITS, ALONG THE FLIP-LID HINGE, AND IN THE BOTTOM OF THE HUMIDIFIER CHAMBER. DURING INTERNAL INVESTIGATION OBSERVED DUST ON AND IN THE BLOWER. OBSERVED A DUSTY SMOKE (NON-TOBACCO) ODOR. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND ONE ERROR CODE. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES THERE WAS EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTU

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 23520278 ↗
• InjuryNov 11, 2025Contamination; Degraded; Contamination; Degraded

  A DEVICE WAS RETURNED TO MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING TWO SKIN CANCERS ON FACE BY NASAL AREA, COUGH, AND THROAT IRRITATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THE BASE UNIT. THE MANUFACTURER INSPECTED EXTERNALLY AND INTERNALLY, OBSERVED LIQUID INGRESS AND MINERAL SPOTS ON BLOWER AND BLOWER BOX. DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AIRPATH, DIRT CONTAMINATION ON FLIP LID SEAL, AND INDETERMINATE CONTAMINATION THROUGHOUT ENCLOSURE SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND

  Patient problems: Cancer; Cough; No Clinical Signs, Symptoms or Conditions; Sore Throat

  MAUDE report 23520276 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THIS IS RELATED TO THE DEVICE DREAMSTATION HUMIDIFIER. THE PATIENT HAS ALLEGED TO VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE MANUFACTURER CONFIRMED EVIDENCE OF FOAM DEGRADATION WHICH WAS OBSERVED IN THE BASE UNIT. THERE WERE SOME SECONDARY FINDINGS. DURING INVESTIGATION, ORANGE CONTAMINATION FOUND ON THE BOTTOM OF BOTH BASE UNIT AND HUMIDIFIER. DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH. EVIDENCE OF WATER INGRESS ON THE BLOWER AND BLOWER BOX ENCLOSURE. BIO CONTAMINANT WAS FOUND ON FLIP LID SEAL OF HUMIDIFIER. CORROSION ON P4 POWER PORT. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND ONE ERRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520186 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION PATIENT STATED THE REPLACEMENT DS1 TURNED OFF DURING USE AND COMPLAINED THE HEATED TUBING WAS TOO HOT AND BURNED THE PATIENT¿S SKIN WHEN TOUCHED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED DUST-LIKE CONTAMINATION ON THE FLIP LID, THE BOTTOM COVER, THE ISO (INTERNATIONAL ORGANIZATION OF STANDARDIZATION) PORT, THE ISO PORT COVER, AND THE HEATER PLATE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER WAS NOT ABLE TO CONFIRM THE COMPLAINT OF THE WHOLE DEVICE FEELING HOT OR THE COMPLAINT OF THE HUMIDIFIER NOT WORKING. THE MANUFACTURER SERVICE CENTER CONCLUDES THE COMPLAINT OF THE DEVICE NOT TURNING ON OR THE COMPLAINT OF THE DEVICE TURNING OFF DURING USE. PIL WAS NOT ABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520183 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAMSTATION HUMID. THE MANUFACTURER RECEIVED HUMIDIFIER WITH COMPLAINT OF RUNNY NOSE AFTER USING DEVICE. NO OTHER PERIPHERALS OR ACCESSORIES WERE RETURNED WITH THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION WHICH WAS OBSERVED IN THE BASE UNIT. PIL CAN CONFIRM SOUND ABATEMENT FOAM DEGRADATION, BUT IT IS UNABLE TO DETERMINE IF IT IS THE CAUSE OF THE PATIENT¿S COMPLAINT. PIL FINDS THAT OTHER CONTAMINATIONS LOCATED IN THIS INVESTIGATION WERE SOURCED FROM EXTERNAL ENVIRONMENTAL CONDITIONS. SECONDARY FINDINGS: DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, HUMIDIFIER ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. HUMIDIFIER FLIP LID SEAL WAS SEVERELY YELLOWED. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX AND IT IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED. PIL RETRIEVED THE E

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 23520102 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  A DEVICE WAS RETURNED TO MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, MANUFACTURER OBSERVED KNICKS ON THE EXTERNAL FRONT AREA OF THE TOP ENCLOSURE AND BOTTOM ENCLOSURE. AN UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE FRONT PANEL, BOTTOM ENCLOSURE, ON THE BLOWER, AND BLOWER BOX. EVIDENCE OF LIQUID INGRESS WAS OBSERVED TO THE BLOWER AND BLOWER BOX. A CONTAMINANT CONSISTENT WITH KERATIN WAS OBSERVED TO THE BLOWER BOX. PIL WAS ABLE TO CONFIRM THE PRESENCE FOR DEGRADED SOUND ABATEMENT FOAM RESIDUE IN THE BLOWER BOX. MANUFACTURER CONFIRMED THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM USING A FITT AND THE ASSOCIATED PROCEDURE. INVESTIGATION OF THE HUMIDIFIER WAS PERFORMED, AND PIL OBSERVED AN UNKNOWN DARK CONTAMINANT AROUND THE INTERNAL PORTION OF THE ISO PORT OF THE FLIP LID. A SHINY, OIL LIKE SUBSTANCE WAS OBSERVED ON THE WATER TANK LIFT TRAY. AN UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE LIFT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520033 ↗
• MalfunctionNov 11, 2025Degraded; Excessive Heating; Degraded; Excessive Heating

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAM STATION AUTO BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED PHILIPS WITH THE COMPLAINT OF SPONTANEOUS COMBUSTION. THERE WERE NO REPORTS OF SERIOUS PATIENTS, HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED THE COMPLAINT OF A THERMAL EVENT BUT IS UNABLE TO CONFIRM THE ALLEGATION OF SPONTANEOUS COMBUSTION. DURING INVESTIGATION THE MANUFACTURER OBSERVED THE ROOT CAUSE IS ASSUMED TO BE IGNITION OF O2 IN THE AIRPATH. DUE TO THE EXTENSIVE THERMAL DAMAGE, THE SOUND ABATEMENT FORM WAS UNABLE TO BE EVALUATED FOR EVIDENCE OF DEGRADATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED SOUND ABATEMENT FORM IS UNABLE TO BE EVALUATED FOR DEGRADATION DUE TO EXTENSIVE THERMAL DAMAGE OF THE ENTIRE AIRPATH. THE MANUFACTURER CONCLUDES, THERE WAS NO EVIDEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519968 ↗
• MalfunctionNov 11, 2025Contamination; Degraded; Contamination; Degraded

  A DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. AN EXTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER AND FOUND NO EVIDENCE OF CONTAMINATION. THE MANUFACTURER COMPLETED AN INTERNAL VISUAL INSPECTION. THE MANUFACTURER FOUND NO EVIDENCE OF CONTAMINATION. THE HUMIDIFIER WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. THE MANUFACTURER FOUND EVIDENCE OF CONTAMINATION ON THE FLIP LID OF THE HUMIDIFIER. THE MANUFACTURER FOUND NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND NO ERRORS LOGGED. THE DEVICE WAS APPLIED POWER AND THE DEVICE OPERATED PROPERLY. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION OR BREAKDOWN AND WAS NOT ABLE TO CONFIRM THE COMPLAINT OR ADDRESS THE SYMPTOMS SPECIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519862 ↗
• MalfunctionNov 11, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING COUGHING, SINUS INFECTION, HEADACHE AND FATIGUE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED THAT THERE WERE NO SIGNS OF CONTAMINATION ON THE OUTSIDE OF THE DEVICE. THE DEVICE WAS HOOKED UP TO A KNOWN GOOD POWER SUPPLY AND CORD. AIRFLOW, HEATING PLATE AND HEATED TUBE WERE ALL VERIFIED TO BE OPERATING CORRECTLY. THE CARE ORCHESTRATOR DATA SHOWED THAT THE PATIENT HAD A COMPLIANCE RATING, AND THEY USED THE HUMIDIFIER. THE ERROR LOG SHOWED THAT THERE WERE NO INSTANCES OF ERRORS ON THE DEVICE. THE INTERNAL INVESTIGATION OF THE HUMIDIFIER SHOWED THAT THERE WERE NO SIGNS OF CONTAMINATION IN THE HUMIDIFIER. THE INTERNAL INVESTIGATION SHOWED THAT THERE WERE SIGNS OF CONTAMINATION ON THE INLET PORT. THE

  Patient problems: Cough; Fatigue; Headache; Sinusitis

  MAUDE report 23519539 ↗
• MalfunctionNov 6, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP AND MECHANICAL VENTILATOR DEVICES. THE PATIENT ALLEGES THAT HE IS CONCERNED ABOUT THE FOAM THAT WAS BLOWN INTO HUMIDIFIER PATH AND THE OLD DEVICE WAS CONTAMINATED. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484164 ↗
• InjuryOct 28, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE HYPERSENSITIVITY, NAUSEA, VOMITING, INFLAMMATORY RESPONSE AND LUNG DISEASE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS WAS NOT OBSERVED. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT SCRAPPED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL RE

  Patient problems: Dizziness; Eye Irritation; Headache; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Skin Inflammation/ Irritation; Unspecified Respiratory Problem; Vomiting

  MAUDE report 23401681 ↗