DreamStation DreamStation BiPAP AVAPS30 AAM no Bluetooth, BRRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00606959427211), received between Nov 17, 2024 and Mar 11, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Degraded” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Insufficient Flow or Under Infusion

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A REPORT THAT THE PATIENT WAS USING THE DEVICE NORMALLY, BUT AROUND 5:00 AM THE CIRCUIT DISCONNECTED, AND THE PATIENT WAS WITHOUT THERAPY FOR APPROXIMATELY 30 MINUTES. THIS CAUSED A DROP IN OXYGEN SATURATION (UNSPECIFIED), AND IT WAS STATED THAT "POSSIBLY FOR THIS REASON, THE PATIENT SUFFERED A CARDIAC ARREST." IT WAS REPORTED THAT MEDICAL PROCEDURES WERE PERFORMED (UNSPECIFIED), AND THE PATIENT WAS TREATED AND IS RECOVERING. PER REPORT OF THE EVENT, IT IS UNCLEAR WHETHER A DISCONNECTION ALARM WAS TRIGGERED AND IF THIS ALARM WAS SILENCED. IT WAS REPORTED THAT THE DEVICE LOGS WILL BE RETRIEVED FOR INVESTIGATION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Cardiac Arrest

  MAUDE report 24576347 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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 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 MANUFACTURER SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE MANUFACTURER SERVICE CENTER CONCLUDED THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670322 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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 SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER SERVICE CENTER. THERE WAS ZERO ERROR CODES FOUND. THE MANUFACTURER SERVICE CENTER CONCLUDES THAT THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670134 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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 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 MANUFACTURER SERVICE CENTER. THE MANUFACTURER SERVICE CENTER CONCLUDES THAT THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670130 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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 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 MANUFACTURER SERVICE CENTER. THE MANUFACTURER SERVICE CENTER CONCLUDED THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669961 ↗
• MalfunctionNov 28, 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 CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER'S SERVICE CENTRE. THERE WAS NO ERROR CODE FOUND. THE MANUFACTURER'S SERVICE CENTRE CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669427 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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 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. THE MANUFACTURER SERVICE CENTRE CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669421 ↗
• MalfunctionNov 17, 2024Failure to Power Up; Failure to Power Up

  THE DEVICE WAS RETURNED TO THE MANUFACTURER BECAUSE IT HAD AN ALARM AND FAILED TO TURN ON. THERE IS NO KNOWN PATIENT INVOLVEMENT. THE MANUFACTURER REPAIR TECHNICIAN ORDERED A POWER CABLE, POLLEN FILTER, AND TUBING TO REMEDY THE PROBLEM. THE EVALUATION/REPAIR IS ONGOING, AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702762 ↗

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