DreamStation DreamStation Auto CPAP, GBRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00606959042285), received between Jun 28, 2021 and Nov 15, 2025 — classified as 8 deaths, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Degraded” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER'S 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 MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND POSSIBLE CONTAMINATION OF FOAM DEGRADATION WERE FOUND IN BLOWER AND BLOWER OUTPUT EXHAUST. 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 23563530 ↗
• DeathJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS PASSED AWAY. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION IT IS OBSERVED THAT THERE WAS NO VISIBLE FOAM PARTICLES FOUND. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370631 ↗
• DeathJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE. THE PATIENT HAS PASSED AWAY. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND EVALUATED. EVALUATION RESULT STATED THAT FOAM PARTICLES WERE NOT OBSERVED. 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 REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355913 ↗
• MalfunctionMar 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ABOUT THE LIQUID SPILLAGE OF THE DEVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT THAT PATIENT REQUIRED MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING EVALUATION OF THE DEVICE, REPORTED FAULT WAS CONFIRMED THAT LIQUID INGRESS ON INTERIOR AND EXTERIOR OF DEVICE. THE MANUFACTURER VISUALLY INSPECTED THE INTERNAL/ EXTERNAL PART OF DEVICE AND FOUND MAIN BOARD COMPONENTS BURNT OUT AND CONTAMINATED DUE TO LIQUID INGRESS. IN ADDITION, UI PANEL ASSEMBLY, BLOWER BOX ASSEMBLY, BLOWER ASSEMBLY, UPPER ENCLOSURE, BOTTOM ENCLOSURE, SD COVER FLIP DOOR AND ACCESSORY MODULE FLIP DOOR WERE CONTAMINATED DUE LIQUID INGRESS. SERVICE CENTER ALSO FOUND THAT DEVICE WILL NOT FUNCTION DUE TO LIQUID INGRESS. LASTLY, AS PER CUSTOMER REQUEST THIS DEVICE HAS NOW BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573797 ↗
• DeathNov 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS NOTIFICATION IS BEING REVIEWED DUE TO A USER OF A RENTAL-DREAMSTATION AUTO CPAP DEVICE STATING PATIENT PASSED AWAY AND NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REPORTED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THIS NOTIFICATION AND NO INCREASED RISK TO THE INTENDED USER. THIS DEVICE MEETS UL AND IEC REQUIREMENTS FOR FLAMMABILITY. BASED ON THE INFORMATION AVAILABLE, NO MDR WILL BE FILED. IF UPON EVALUATION OF THE DEVICE A REPORTABLE ISSUE/MALFUNCTION IS IDENTIFIED, THIS DECISION WILL BE RE-EVALUATED USING THE DATE OF THE REPAIR EVALUATION AS THE ""BECOME AWARE"" DATE IF A REPORTABLE ISSUE/MALFUNCTION IS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595289 ↗
• DeathOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS PASSED AWAY. THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR FURTHER EVALUATION. DURING EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THERE WAS NO EVIDENCE OF FOAM PARTICLES FOUND INSIDE THE ASSEMBLY. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20572769 ↗
• DeathOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS PASSED AWAY. 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 20523864 ↗
• DeathSep 11, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  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 PASSED AWAY. THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED BY THE SERVICE TECHNICIAN. EVALUATION RESULT STATED THAT THE COMPLAINT WAS NOT CONFIRMED AND FOUND NO EVIDENCE OF VISIBLE FOAM DEGRADATION. 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 REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195576 ↗
• DeathAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A RENTAL-DREAMSTATION AUTO CPAP PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. 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 19993278 ↗
• DeathJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN DREAMSTATION AUTO CPAP DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE REPORTER DID NOT PROVIDE THE PATIENT'S DATE OF DEATH. THE DEVICE HAS BEEN REQUESTED FOR RETURN. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION, THE DEVICE WILL BE RETURNED TO STOCK. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE THIS DECISION WILL BE RE-EVALUATED USING THE DATE OF THE REPAIR EVALUATION AS THE "BECOME AWARE" DATE IF A REPORTABLE ISSUE/MALFUNCTION IS IDENTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 19541180 ↗
• MalfunctionOct 13, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP 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 12625208 ↗
• MalfunctionOct 4, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573479 ↗
• MalfunctionOct 4, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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 12573439 ↗
• MalfunctionOct 4, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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 12573398 ↗
• MalfunctionOct 4, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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 12573350 ↗
• MalfunctionOct 4, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573336 ↗
• MalfunctionOct 4, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573275 ↗
• InjurySep 29, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP AN UNSPECIFIED ILLNESS. THE PATIENT HAS REQUIRED SURGERY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Insufficient Information

  MAUDE report 12547027 ↗
• MalfunctionSep 23, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE END USER INDICATED THAT OZONE OR ANOTHER UNAPPROVED CLEANING AND DISINFECTION METHOD WAS USED. 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 12522604 ↗
• MalfunctionSep 23, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE END USER INDICATED THAT OZONE OR ANOTHER UNAPPROVED CLEANING AND DISINFECTION METHOD WAS USED. 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 12522549 ↗
• MalfunctionSep 23, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE END USER INDICATED THAT OZONE OR ANOTHER UNAPPROVED CLEANING AND DISINFECTION METHOD WAS USED. 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 12522540 ↗
• MalfunctionSep 23, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE END USER INDICATED THAT OZONE OR ANOTHER UNAPPROVED CLEANING AND DISINFECTION METHOD WAS USED. 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 12522531 ↗
• MalfunctionSep 13, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 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 12462705 ↗
• MalfunctionJun 28, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR 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 12075040 ↗