DreamStation DreamStation BiPAP AVAPS30 AAM w/Humid w/H Tube, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00606959425521), received between Nov 17, 2024 and Sep 25, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Degraded” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K102465); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Degraded

  A DreamStation BiPAP AVAPS30 device was returned 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, the service technician observed visible foam particles. The device was scrapped by the service center after the evaluation was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898321 ↗
• MalfunctionMar 4, 2026Degraded

  A DEVICE WAS RETURNED TO 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 EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512781 ↗
• MalfunctionMar 4, 2026Degraded

  A DEVICE WAS RETURNED TO 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 EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED AND THERE NO SECONDARY FINDINGS FOUND..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511001 ↗
• MalfunctionOct 15, 2025Degraded; Degraded

  A DREAMSTATION BIPAP DEVICE WAS RETURNED TO THE 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. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE SERVICE TECHNICIAN OBSERVED THAT ERROR CODES E105 (ERR_HUMID_AMBIENT_COMM), E200 (ERR_RTOS_ABORT_ERROR) AND E053 (ERR_COMP_LOG_SEM_TIMEOUT) WERE PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305510 ↗
• MalfunctionOct 15, 2025Degraded; Degraded

  A DREAMSTATION BIPAP DEVICE WAS RETURNED TO THE 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. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE SERVICE TECHNICIAN OBSERVED THAT ERROR CODES E176 (ERR_BT_BIST_FAIL) AND E223 (ERR_LOW_PRESSURE_REGULATION) WERE PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294771 ↗
• MalfunctionJun 9, 2025Flare or Flash; Flare or Flash

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A DREAMSTATION BIPAP AVAPS DEVICE. THERE IS AN ALLEGATION FROM A USER THAT THEY SAW SPARKS COMING FROM THE DEVICE AND WHEN THEY UNPLUGGED THE UNIT, THE SPARKS STOPPED. THE USER ALSO ALLEGES THE DEVICE SMELLED HOT. 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 22172193 ↗
• MalfunctionJun 3, 2025Degraded; Degraded

  A DREAMSTATION BIPAP AVAPS30 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT A THIRD PART SERVICE CENTER, VISIBLE FOAM DEGRADATION WAS FOUND. THERE IS NO DOCUMENTATION OF WHAT NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133459 ↗
• MalfunctionJun 2, 2025Degraded; Degraded

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, VISIBLE FOAM DEGRADATION WAS FOUND. NO REPAIRS WERE PERFORMED; THE DEVICE WAS DISPOSITIONED TO BE SCRAPPED. ADDITIONALLY, ERROR CODES WERE FOUND WHEN THE ERROR LOG WAS CHECKED. THIS DEVICE IS NOT A LIFE-SUSTAINING DEVICE. NO REPAIRS WERE PERFORMED; THE DEVICE WAS DISPOSITIONED TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126297 ↗
• MalfunctionMay 19, 2025Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION THAT A DREAMSTATION BIPAP AVAPS 30 DEVICE WAS RETURNED FOR SERVICE AND EVALUATION. DURING THE EVALUATION, VISIBLE FOAM PARTICLES AND FOAM DEGRADATION WAS OBSERVED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE'S SOUND ABATEMENT FOAM REQUIRES REPLACEMENT TO ADDRESS THE ISSUE. THIS RECORD WILL BE INCLUDED IN A-06-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045883 ↗
• MalfunctionMar 26, 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 AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE SERVICE CENTER. THERE WERE ERROR CODES FOUND. UPON FURTHER EVALUATION, VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701925 ↗
• MalfunctionJan 21, 2025Degraded; Degraded

  THE DEVICE WAS EVALUATED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED AS REQUIRED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197340 ↗
• MalfunctionJan 8, 2025Degraded; Degraded

  THIS COMPLAINT HAS BEEN REVIEWED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, AT THE MANUFACTURE'S SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND CONFIRMED VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106444 ↗
• MalfunctionJan 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A30 WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060206 ↗
• MalfunctionNov 17, 2024Degraded; Degraded

  A 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 FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102465. One submission often covers many models, so check the product and lot details in each record.

• Z-1973-2021 · Jun 14, 2021 · Open, Classified
  DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironic