DreamStation 2Recalls & reported problems across all models

We found 2 models of DreamStation 2 by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between May 5, 2023 and Aug 27, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DreamStation 2 problems

DreamStation 2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DreamStation 2 00

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  27 reports
• DreamStation 2 DreamStation 2 Advanced Auto CPAP with Humidifier, Cellular, Bluetooth for BL

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  18 reports

Recent DreamStation 2 adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 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 ↗

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