DreamStation DreamStation BiPAP AutoSV, EURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959425842), received between Jul 12, 2023 and Mar 24, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 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 PATIENT ALLEGES VISUALIZATION OF PARTICLES IN 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 21676561 ↗
• InjuryJul 12, 2023Degraded; 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. THE PATIENT ALLEGED HAVING CONJUNCTIVITIS, SKIN PROBLEMS, IRRITATION OF THE RESPIRATORY TRACT, VOMITING, NEUROLOGICAL DISORDERS - SEIZURES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE IS CURRENTLY AT THE THIRD-PARTY SERVICE CENTER BUT THE EVALUATION HAS NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS RECEIVED THE EVALUATION OF THE DEVICE.

  Patient problems: Conjunctivitis; Convulsion/Seizure; Insufficient Information; Skin Disorders; Unspecified Respiratory Problem; Vomiting

  MAUDE report 17304852 ↗