DreamStation 2 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00606959062757), received between May 5, 2023 and Aug 27, 2026 — classified as 27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Thermal Decomposition of Device

  A device was returned to a third-party service center and during the evaluation of the device, the third-party service center visually inspected the device and found evidence of the unit's PCA was defective and that a thermal event had occurred.The device was forwarded to PIL. The manufacturer's investigation is ongoing. A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478644 ↗
• MalfunctionAug 6, 2026Thermal Decomposition of Device

  The device was sent to a third-party service center for investigation. During evaluation, the third-party service center found that PCA is burned, and the UI panel has burn damage. Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation. A final report will be sent once the investigation is concluded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155675 ↗
• MalfunctionAug 5, 2026Thermal Decomposition of Device

  The manufacturer was contacted in reference to the DS2Adv Auto CPAP device. There was a report of error message "needs repair". 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 Third-party service center for evaluation. During the evaluation of the device there was evidence of Component on PCA is burned, the blower is corroded, the bower outlet seal/isolator, inlet/ outlet seal, ISO port are contaminated ISO port are contaminated with limestone, the screws are rusted. Pollen filter needs to be added for preventive maintenance. The device was requested to be sent to the manufacturer's Product Investigation Lab (PIL) for further investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143102 ↗
• MalfunctionMay 25, 2026Fire; Smoking

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO DS2ADV AUTO CPAP DEVICE THAT SMOKE AND FLAME WAS EMITTED FROM THE HUMIDIFIER WHEN IT WAS POWERED ON AGAIN USING THE REPLACEMENT POWER CORD. THE REPORTED EVENT MAKES NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272754 ↗
• MalfunctionMay 3, 2026Overheating of Device

  A DREAMSTATION 2 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER ALLEGING THE DEVICE TURNS OFF ON ITS OWN. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED A BURNED PCA. THE DEVICE HAS BEEN FORWARDED TO THE PRODUCT INVESTIGATION LAB FOR FURTHER EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064139 ↗
• MalfunctionDec 18, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DS2ADV AUTO CPAP DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING EVALUATION, THE DEBUG TECHNICIAN NOTICED THAT THE PCA HAD A THERMAL EVENT; THEREFORE, THE DEFECTIVE AFFECTED PCA NEEDS TO BE CHANGED. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WAS FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843232 ↗
• MalfunctionDec 9, 2025Overheating of Device; Overheating of Device

  A DREAMSTATION 2 ADVANCED AUTO CPAP WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR A REPAIR. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE'S PRINTED CIRCUIT ASSEMBLY IS BURNT. THE INVESTIGATION IS ONGOING. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759545 ↗
• MalfunctionDec 4, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DS2ADV AUTO CPAP DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER, AND THE SERVICE CENTER FOUND A SHORT CIRCUIT ON THE PCA, BURNED COMPONENTS, AND A BURNED SMELL INSIDE. THE UI PANEL FLAT CABLE WAS BURNED, THE ISO PORT WAS CONTAMINATED AND HAD BURN MARKS ON IT, AND THE INLET/OUTLET SEAL WAS CONTAMINATED AND ALSO HAD BURN MARKS. THE HEATER PLATE, BLOWER BOX, BLOWER AND BLOWER OUTLET SEAL, TOP ENCLOSURE, BOTTOM ENCLOSURE, AND CENTER ENCLOSURE WERE ALL CONTAMINATED WITH PARTICLES AND SMELLED BURNED INSIDE. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WAS FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716487 ↗
• MalfunctionNov 25, 2025Overheating of Device; Overheating of Device

  A DS2ADV AUTO CPAP DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THE SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND PCA SHORT, UI BEZEL FLAT CABLE BURNT. THERE WAS NO EVIDENCE OF FOAM PARTICLES OR DEGRADATION. 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 23643523 ↗
• MalfunctionNov 3, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NEEDS TO BE CHECKED RELATED TO THE DEVICE DS2ADV AUTO CPAP. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THERMAL EVENT AS THE MAIN PCA WAS BURNT. ADDITIONALLY, BLOWER AND SCREWS WERE CORRODED, AND NEW POLLEN FILTER MUST BE ADDED. THE CUSTOMER COMPLAINT WAS REPRODUCED. THE THIRD-PARTY SERVICE CENTER WAS UNABLE TO COMPLETE THE INVESTIGATION, AND THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY (PIL) AND INVESTIGATED FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452119 ↗
• MalfunctionOct 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A DS2ADV AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND PCA SHORT, UI BEZEL RIBBON CABLE BURNT. 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 23404210 ↗
• MalfunctionOct 24, 2025Circuit Failure; Circuit Failure

  A DS2ADV AUTO CPAP DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS PCA AND UI PANEL WAS BURNED. 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 23383140 ↗
• MalfunctionSep 12, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING DREAMSTATION AUTO CPAP SCREEN DOES NOT SWITCH ON. THE DEVICE WAS NOT KNOWN TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DREAMSTATION CPAP DEVICE WAS RETURNED TO THE MANUFACTURE'S THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE'S PCA AND ISO PORT WAS MELTED. DISPLAY RIBBON CABLE WAS BURNT. ADDITIONALLY, THE FOLLOWING PARTS WERE CONTAMINATED, INLET /OUTLET SEAL/ISOLATOR POLLEN FILTER NEEDS REPLACING DUE TO PREVENTIVE MAINTENANCE. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF NEW ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037614 ↗
• MalfunctionSep 10, 2025Temperature Problem; Overheating of Device; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SYSTEM ERROR ON A DS2ADV AUTO CPAP DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE PHILIPS SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DS2ADV AUTO CPAP HAD A BURNED AND CORRODED PCA. THE DEVICE WILL BE RETURNED TO THE PIL FOR ADDITIONAL TESTING. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME. 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. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022281 ↗
• MalfunctionAug 11, 2025Device Emits Odor; Device Emits Odor

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING BURNING SMELL. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT.THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770648 ↗
• MalfunctionAug 8, 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. CUSTOMER COMPLAINT THE MACHINE TURNS OFF AND ON WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, THEY FOUND PCA IS BURNT, HUMIDIFIER WATER TANK IS CONTAMINATED, ISO PORT AND INLET/OUTLET SEAL ARE CONTAMINATED, HEAT PLATE AND BLOWER ARE NOT FUNCTIONAL, POLLEN FILTER NEEDS REPLACEMENT DUE TO PREVENTIVE MAINTENANCE. DEVICE RETURN TO PIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750723 ↗
• MalfunctionJul 19, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A DREAMSTATION 2 CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO A COMPLAINT OF USING UP THE WATER. DURING THE INITIAL EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE UNIT AND FOUND THE PCA HAD THERMAL DAMAGE. IT WAS ALSO NOTED THAT THE BLOWER WAS DEFECTIVE, AND THE POLLEN FILTER NEEDS TO BE REPLACED. THERE WAS NO ALLEGATION OF PATIENT HARM OR INJURY. THE DEVICE WAS REPAIRED BY THE THIRD-PARTY SERVICE CENTER. THE PCA, BLOWER, AND POLLEN FILTER WERE REPLACED. THE DEVICE WAS SERVICED, INSPECTED, AND TESTED BY THE THIRD-PARTY SERVICE CENTER AND PASSED THE TESTING REQUIREMENTS SET BY THE MANUFACTURER. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22550350 ↗
• MalfunctionJun 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A DREAMSTATION 2 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO A COMPLAINT OF DOES NOT START. DURING THE INITIAL EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE UNIT AND FOUND THE PCA HAD THERMAL DAMAGE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. 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 22210789 ↗
• MalfunctionMay 26, 2025Overheating of Device; Insufficient Device Problem Information; Insufficient Device Problem Information

  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. CUSTOMER COMPLAINT THE MACHINE TURNS OFF AND ON WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, THEY FOUND PCA IS BURNT, INLET/OUTLET SEAL IS MISSING, ISO PORT IS CONTAMINATED AND POLLEN FILTER NEEDS REPLACING DUE TO PREVENTIVE MAINTENANCE. DEVICE 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 22084466 ↗
• MalfunctionMay 8, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DREAMSTATION 2 DEVICE. THERE IS AN ALLEGATION THAT THERE IS A SMELL OF BURNING FROM THE DEVICE. 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 21990060 ↗
• MalfunctionApr 16, 2025Overheating of Device; Smoking; Sparking; Overheating of Device; Smoking; Sparking

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A THERMAL MALFUNCTION OF A DREAMSTATION 2 DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SPARK AT THE PNEUMATIC INLET PORT. ADDITIONALLY, IT WAS REPORTED THAT SMOKE WAS OBSERVED AND A BURNING SMELL. THERE WAS NOT REPORTED HARM OR SERIOUS INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE THE HOME REFERRAL SERVICE VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF A DAMAGED MOTHERBOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21852751 ↗
• MalfunctionMar 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DS2ADV AUTO CPAP DEVICE DOES NOT LIGHT UP. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT THAT PATIENT REQUIRED MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION AND THE REPORTED CUSTOMER COMPLAINT WAS REPRODUCED. DURING EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND NO LIGHT FROM DISPLAY, UI BEZEL DEFECTIVE, MAIN BOARD BURN, BLOWER OUTLET SEAL DEFORMED, BLOWER CONTAMINATED INSIDE, IN/OUT SEAL MISSING AND NEW POLLEN FILTER MUST ADDED. LASTLY, THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617582 ↗
• MalfunctionFeb 28, 2025Device Emits Odor; Device Emits Odor

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A THERMAL COMPLAINT ON A DREAMSTATION 2. THE MANUFACTURER RECEIVED INFORMATION ALLEGING BURNING SMELL. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED 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 21490611 ↗
• MalfunctionFeb 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE DREAM STATION 2. THE MANUFACTURER RECEIVED INFORMATION ALLEGING PARTICLES IN CIRCUIT AND MASK. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE PATIENT ALLEGES A COUGH AND FEELING AS IF SHE HAS ANGINA. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Angina; Cough

  MAUDE report 21375155 ↗
• MalfunctionDec 13, 2023Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION IN REGARD TO A DREAMSTATION 2 ADVANCED AUTO CPAP DEVICE. THE PATIENT ALLEGES THAT DURING AN ANNUAL VISIT, THE TECHNICIAN SAW THAT ONE SIDE OF THE MEDICAL DEVICE HAD MELTED. IN ADDITION, THE PATIENT DOES NOT USE THE BUILT-IN HUMIDIFIER AND IT WAS NOTED THAT THE HUMIDIFIER WAS SET TO 5. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER ON APRIL 11TH, 2023, AND IS AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318018 ↗