REMstar SE REMstar SE with SD Slot, US (REF 220P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00606959038356), received between Oct 24, 2017 and Jul 9, 2025 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Degraded” (18 reports).

1 other recall cover devices cleared under the same FDA submission (K130077); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Degraded; Smoking; Degraded; Smoking

  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 SMOKE COMING OUT AND FILTER WAS BLACK. 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 PRODUCT INVESTIGATION LABORATORY (PIL) FOR INVESTIGATION. AN EXTERNAL AND INTERNAL INSPECTION OF THE DEVICE PERFORMED BY QA DURING THIS INVESTIGATION FOUND NO EVIDENCE OF THERMAL DAMAGE OR FAILURE OF THE DEVICE. QA ALSO TESTED THE DEVICE ON THE MULTI-FUNCTION TEST STATION (MFTS) AND ALL TESTS PASSED AS WELL. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462764 ↗
• InjuryJun 2, 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 RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, KIDNEY DISEASE, THER PERSISTENT COUGH, STROKE, IRRITABLE ESOPHAGUS SYNDROME. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cough; Dizziness; Headache; Insufficient Information; Stroke/CVA; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 22123806 ↗
• MalfunctionJun 2, 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 HEADACHES, VOMITING, COUGH, SHORTNESS OF BREATH, CHEST PAIN, SINUS CONGESTION, DIZZINESS AND BLURRY VISION. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Blurred Vision; Chest Pain; Cough; Dizziness; Dyspnea; Headache; Sinusitis; Vomiting

  MAUDE report 22122282 ↗
• InjuryJun 2, 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 KIDNEY CANCER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Cancer

  MAUDE report 22121627 ↗
• InjuryMay 30, 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 RESPIRATORY TRACT IRRITATION, ASTHMA (NEW OR WORSENING), RESPIRATORY DISTRESS, REACTIVE AIRWAY DISEASE AND GASTROINTESTINAL ISSUES. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Asthma; Unspecified Gastrointestinal Problem; Unspecified Respiratory Problem

  MAUDE report 22114183 ↗
• MalfunctionNov 4, 2024Degraded; 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 EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, DIZZINESS, HEADACHE AND OTHER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Dizziness; Eye Irritation; Headache; Insufficient Information; Skin Inflammation/ Irritation; Unspecified Respiratory Problem

  MAUDE report 20595997 ↗
• InjuryOct 25, 2024Degraded; 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 KIDNEY DISEASE/TOXICITY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 20532841 ↗
• InjuryOct 25, 2024Degraded; 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 EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY, NAUSEA / VOMITING, ASTHMA (NEW OR WORSENING), KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY, 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 HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Asthma; Dizziness; Eye Irritation; Headache; Hypersensitivity/Allergic reaction; Nausea; Skin Inflammation/ Irritation; Unspecified Hepatic or Biliary Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem; Vomiting

  MAUDE report 20530301 ↗
• MalfunctionDec 4, 2023Degraded; 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 SHE HAS BEEN BREAKING OUT IN HIVES, UPPER RESPIRATORY AND NAUSEA FOR THE PAST YEAR. ALSO IS GOING TO SPECIALIST. 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: Nausea; Unspecified Respiratory Problem

  MAUDE report 18257183 ↗
• MalfunctionMay 15, 2023Degraded; Fire; Device Emits Odor; Smoking; Degraded; Fire; Device Emits Odor; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING OF A THERMAL EVENT TO A REMSTAR SE DEVICE. THE USER ALLEGES THE BATTERY EXPLODED AND THE DEVICE DOES NOT RETAIN WATER. THE USER WAS INFORMED BY THE MANUFACTURER THAT THIS DEVICE DOES NOT CONTAIN A BATTERY AND QUESTIONED USER IF HE WAS REFERRING TO THE POWER SUPPLY OF THE DEVICE. THE USER STATED HE WOULD SEND PHOTOS, BUT THE PHOTOS HAVE YET TO BE RECEIVED. THE USER WAS REQUESTING A NEW DEVICE. THE USER ALLEGES THERE WAS A BURNING ODOR, HE SAW SMOKE AND HEARD A LOUD POP, AND THEN HE SAW A SMALL FLAME WHICH HAD TO BE EXTINGUISHED WITH A LITTLE BIT OF WATER. THE USER ALLEGES THE BACK OF HIS HEADBOARD ON HIS BED WAS BURNT. THERE WAS NO EVIDENCE OF MELTING OR EXPOSED WIRES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT RETURNED TO THE MANUFACTURER. 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 16929726 ↗
• MalfunctionMay 3, 2023Degraded; 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 DIFFICULTY BREATHING, SOUNDS FROM DEVICE WHEN INHALING AND EXHALING. 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: Dyspnea

  MAUDE report 16860171 ↗
• MalfunctionNov 7, 2022Degraded; 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 ALLEGED TO THROAT IRRITATION AND AIR LOSSING DURING NIGHT. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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: Dyspnea; Sore Throat

  MAUDE report 15743755 ↗
• MalfunctionSep 13, 2022Degraded; 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 ALLEGED TO EXPERIENCING SNEEZING AND A WATERY NOSE AFTER USE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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: Fluid Discharge; Sneezing

  MAUDE report 15412566 ↗
• MalfunctionMar 29, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES DISCOLOURATION OF FILTER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13940600 ↗
• MalfunctionMar 3, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. NO ALLEGATION OF PATIENT HARM OR INJURY WAS REPORTED. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663918 ↗
• MalfunctionFeb 28, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND PARTICLE CONTAMINATION WAS OBSERVED IN THE DEVICE'S BLOWER DURING DEVICE EVALUATION RESULTING IN BLOWER BOX REPLACEMENT. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625335 ↗
• MalfunctionFeb 24, 2022Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAD INFORMED MOLD IN THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595563 ↗
• MalfunctionFeb 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589303 ↗
• InjuryOct 24, 2017Device Operational Issue; Device Operational Issue

  AN END USER ALLEGES SHE DEVELOPED RECEDING GUMS DUE TO INADEQUATE HUMIDIFICATION WHILE USING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE AND ASSOCIATED HUMIDIFIER. THE USER REPORTED UNDERGOING SURGERY TO CORRECT HER RECEDING GUMS. THE PATIENT DISCONTINUED THERAPY APPROXIMATELY FOUR MONTHS PRIOR TO THE COMPLETION OF THE DENTAL PROCEDURE. THE MANUFACTURER RECEIVED THE CPAP AND HEATED HUMIDIFIER FOR EVALUATION AND COULD NOT CONFIRM THE USER'S ALLEGATION. THERE WERE NO OPERATIONAL OR HUMIDIFICATION ISSUES WITH THE DEVICES. BOTH UNITS PASSING ALL TESTING AND FUNCTIONED AS DESIGNED. THE DURABLE MEDICAL EQUIPMENT (DME) PROVIDER STATES THE PATIENT HAD VERY POOR COMPLIANCE AND OVERALL POOR TOLERANCE OF THE CPAP THERAPY WHILE USING THE DEVICE BETWEEN (B)(6) 2017. A REVIEW OF THE DATA INDICATES THERE WAS HUMIDIFICATION DURING ALL THERAPY SESSIONS. THE HEATED HUMIDIFIER IS AN ACCESSORY FOR THERAPY DEVICES TO PROVIDE MOISTURE TO THE PATIENT CIRCUIT. IT IS INTENDED FOR USE IN SPONTANEOUSLY BREATHING PATIENTS WEIGHING OVER (B)(6) KG ((B)(6) LBS.), IN THE HOME OR HOSPITAL/INSTITUTIONAL ENVIRONMENT, WHO USE MASK-APPLIED POSITIVE PRESSURE VENTILATION THERAPY. LABELING INSTRUCTS THE USER TO P

  Patient problems: Tissue Damage

  MAUDE report 6972679 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130077. One submission often covers many models, so check the product and lot details in each record.

• Z-1974-2021 · Jun 14, 2021 · Open, Classified
  SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide