DreamStation 2 DreamStation 2 Advanced Auto CPAP with Humidifier, Cellular, Bluetooth for BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00606959062818), received between Oct 30, 2023 and Apr 14, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Excessive Heating

  A DREAM STATION 2 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE HAD A BURNED PCA. ADDITIONAL FINDINGS INCLUDE A MISSING INLET/OUTLET SEAL, WHICH NEEDS TO BE REPLACED. THE ISO PORT IS CONTAMINATED AND SHOWS SIGNS OF MELTING WHEN THE BURN OCCURRED. THE BLOWER IS NOISY AND NEEDS TO BE REPLACED. THE HEATER PLATE IS CORRODED. THE POLLEN FILTER MUST BE REPLACED DUE TO PREVENTIVE MAINTENANCE. ADDITIONALLY, THE FLEX CABLE FROM THE UI BEZEL IS BURNED. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24869732 ↗
• MalfunctionFeb 2, 2026Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CHIP WAS BLOWN ON PCB OCCURRED ON A DS2 ADV AUTO CPAP. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233814 ↗
• MalfunctionJan 22, 2026Overheating of Device

  THE DS2 ADV AUTO CPAP WAS RETURNED TO PLEXUS THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED THAT THE DEVICE COMPONENT ON PCA WAS BURNED. THE ISO PORT ALSO BURN DAMAGE. UI BEZEL IS SCRATCHED AND NEED TO BE REPLACED. THE USB COVER IS MISSING AND NEEDS TO BE RE-ADDED. POLLEN FILTER NEEDS TO BE ADDED FOR PREVENTIVE MAINTENANCE 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 24153288 ↗
• MalfunctionNov 24, 2025Thermal Decomposition of Device; Overheating of Device; Thermal Decomposition of Device; Overheating of Device

  THIS NOTIFICATION WAS OPENED FOR REVIEW DUE TO INFORMATION RECEIVED ON A DREAMSTATION 2 ADVANCED AUTO CPAP DEVICE RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT A COMPONENT IS BLOWN ON THE PCA. THE RIBBON CABLE ON THE IU BEZEL AND PCA NEED TO BE REPLACED. THE ISO HAS DRIED WATER MARKS. POLLEN FILTERS WERE ALSO ADDED FOR PREVENTATIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640125 ↗
• MalfunctionNov 20, 2025Thermal Decomposition of Device; Overheating of Device; Thermal Decomposition of Device; Overheating of Device

  A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE /RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THE PCA HAS CORROSION AND SHORT ON IT AND NEEDS TO BE REPLACED. THE BLOWER BOX, BLOWER, ISO PORT BURNT. THE HEATER PLATE WAS CORRODED AT THE CONNECTOR, AND UI BEZEL FLAT CABLE WAS BURNT AS WELL. POLLEN FILTER WAS ADDED FOR PREVENTIVE MAINTENANCE, AND THE SOFTWARE WAS UPDATED TO NEWEST VERSION. THE DEVICE WAS REPAIRED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612913 ↗
• MalfunctionNov 4, 2025Smoking; Smoking

  THIS NOTIFICATION WAS OPENED FOR REVIEW DUE TO AN ALLEGATION OF DREAMSTATION 2 AUTO CPAP ADVANCED DEVICE, WHICH WORKED FOR A MINUTE, THEN STOPPED AND STARTED SMOKING.THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464223 ↗
• MalfunctionOct 16, 2025Overheating of Device; Overheating of Device

  A DREAMSTATION 2 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE PCA WAS BURNT. IN CONCLUSION, THE DEVICE PCA NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE THE INLET AND OUTLET SEAL IS MISSING AND THE POLLEN FILTER NEEDS TO BE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION. THE DEVICE HAS BEEN FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311895 ↗
• MalfunctionAug 5, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DS2 ADV AUTO CPAP DEVICE. THE PATIENT HAS ALLEGED HUMIDIFIER DOES NOT WORK. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN FOUND PCA WAS BURNED DURING THE DEVICE EVALUATION. ALTHOUGH THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, THIS COMPLAINT IS REPORTABLE BECAUSE THE REPORTED ISSUE/EVENT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THE FAULTY UNIT WILL BE RETURNED TO THE PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURE'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22712674 ↗
• MalfunctionAug 1, 2025Circuit Failure; Overheating of Device; Circuit Failure; Overheating of Device

  THE MANUFACTURER BECAME AWARE OF A DS2ADV AUTO CPAP DEVICE WAS CONTACTED IN REFERENCE TO A THERMAL PRODUCT MALFUNCTION. THE SERVICE CENTER RECEIVED INFORMATION ALLEGING PCA BURNED. THERE IS NO ALLEGATION OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. DURING THE TECHNICIAN'S REPAIR, THE TECHNICIAN NOTICED PCA BURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692948 ↗
• MalfunctionAug 1, 2025Temperature Problem; Temperature Problem

  THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND NO VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND PCA, UI BEZEL'S RIBBON CABLE WAS BURNT, AND ISO PORT IS MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688498 ↗
• MalfunctionJul 28, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DS2 ADV AUTO CPAP DEVICE'S THERMAL EVENT. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DEVICE HAS A "BURNING SMELL". THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THE PATIENT REQUIRED NO MEDICAL INTERVENTION. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22630217 ↗
• MalfunctionJul 18, 2025Overheating of Device; Overheating of Device

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE THEY FOUND THAT THE PCA IS BURNT , ISO PORT, INLET/OUTLET SEAL, BLOWER BOX, BLOWER AND BLOWER OUTLET SEAL ARE CONTAMINATED, POLLEN FILTER NEEDS REPLACEMENT DUE TO PREVENTIVE MAINTENANCE PASSED TEST FOR DECONTAMINATION, EVALUATION, PACKAGING. DEVICE IS RETURNED UNREPAIRED. REPORTABLE SINCE DEVICE ISSUE/EVENT HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22547190 ↗
• MalfunctionJul 4, 2025Contamination; Device Emits Odor; Contamination; Device Emits Odor

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A THERMAL COMPLAINT ON A DS2 ADV AUTO CPAP DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGED OF HAVING SMELL OF BURNING FROM THE DEVICE. THERE IS NO ALLEGATION OF PATIENT HARM OR INJURY. MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. DURING THE EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND HEATER PLATE, BLOWER, AND ISO PORT IS CONTAMINATED, PCA AND UI BEZEL IS DEFECTIVE, INLET/OUTLET SEAL MISSING, POLLEN FILTER. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403579 ↗
• MalfunctionMar 25, 2025Thermal Decomposition of Device; Thermal Decomposition of Device; Overheating of Device

  A DREAMSTATION 2 CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO A COMPLAINT OF NOT TURNING ON. DURING THE INITIAL EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE UNIT AND FOUND THE PCA HAD THERMAL DAMAGE. THERE WAS NO ALLEGATION OF PATIENT OR USER HARM/INJURY. 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 21689859 ↗
• MalfunctionJan 6, 2025Fire; Fire

  THE DS2ADV AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, NO FOAM PARTICLES WERE FOUND WITHIN THE DEVICE AND THE COMPLAINT WAS CONFIRMED AND CABLE BURNED. ALSO, ADDITIONAL FAILURE WORK SCREEN. THE MANUFACTURER RECEIVED INFORMATION DOES NOT START ANYMORE. THE DEVICE WAS SCRAPPED FOLLOWING THE EVALUATION. 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 21085861 ↗
• MalfunctionMar 26, 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 ALLEGING VISUALIZATION OF GREYISH PARTICLES IN THE DEVICE WATERBANK. THE PATIENT HAS CONTACTED MEDIQ (THE DISTRIBUTOR) WITH THIS COMPLAINT BUT DOES NOT FEEL HE IS TAKEN SERIOUSLY. THE PATIENT REPORTS VISUALIZATION OF GRAY FLAKES SEVERAL TIMES IN THE MORNING EVEN WHEN USAGE WAS SHORT. THE PATIENT ALSO REPORTS BEING AWAKEN BY A PERSISTENT RUNNY NOSE WITH SUBSEQUENT SNEEZING. THE PATIENT'S DEVICE HAS BEEN EXCHANGED A FEW TIMES. 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: Sneezing; Unspecified Respiratory Problem

  MAUDE report 18980224 ↗
• MalfunctionJan 18, 2024Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DREAMSTATION 2 ADV AUTO CPAP DEVICE. THE PATIENT STATES "THE WATER TANK IS EMPTY IN THE MORNING", THE HUMIDIFIER CONTINUES TO HEAT AFTER THE WATER HAS EVAPORATED, A BURNING SMELL, "HEATING [IS] OUT OF ORDER", AND "THE HEATER IS BECOMING QUITE WARM." THEY HAVE BEEN USING THIS NEW DEVICE FOR A FEW WEEKS NOW AND HAD "SENT THE FIRST ONE BACK TO [THE DME] BECAUSE THE HEATING OFTEN DID NOT WORK" AND "KEPT THE RESERVOIR FILLED TO THE BRIM WITH WATER". ON THE NIGHT OF DEC-02-2023, "ALL THE WATER EVAPORATED" AND IT WAS "THE FIRST TIME A DEFECT HAS OCCURRED WITH THIS SECOND [DEVICE]." THE PATIENT ALLEGES THEIR LUNGS WERE SORE, IRRITATION WITH THEIR MUCOUS MEMBRANES, AND "FELT A RUSH OF COLD AIR" WHEN THEY WOKE UP IN THE MORNING. THE HUMIDITY IN THE BEDROOM "WAS ABOUT 69% DURING THE NIGHT" WHEN THEY "MEASURED THIS WITH A SCIENTIFIC HUMIDITY METER" WHICH THEY STATE, "THIS IMPLIES THAT THE PRESSURE SWITCH OF THE HEATING ELEMENT WAS FUNCTIONING." IN ADDITION, THE PATIENT STATES "THE HEATING CONTINUED TO HEAT APPEARS TO BE BECAUSE IT DID NOT GO OUT AT THE SET POINT." THEY ARE CONCERNED "NOT SO MUCH THAT THE RESERVOIR WILL BECOME DRY, BUT WHETHER T

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18540327 ↗
• MalfunctionOct 30, 2023Degraded; Material Integrity Problem; Degraded; Material Integrity Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF DS2ADV AUTO CPAP THAT THE PATIENT ALLEGES THAT HE/SHE FOUND BLACK PARTICLES IN THE PILLOW WHEN HE/SHE WOKE UP. 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 18035966 ↗