DreamStation DreamStation BiPAP AutoSV, DERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959425781), received between Oct 26, 2023 and Apr 19, 2024 — classified as 1 death, 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.

• DeathApr 19, 2024Degraded; 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 EXHAUSTION, NAUSEA, HEADACHES, SHORTNESS OF BREATH, CHOKING ATTACKS, DIFFICULTY SWALLOWING AND DEATH. IN ADDITION, PATIENT ALLEGES FILTERS WERE COMPLETELY BLACK EVERY MORNING. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Dysphagia/ Odynophagia; Dyspnea; Extreme Exhaustion; Headache; Nausea

  MAUDE report 19145264 ↗
• MalfunctionOct 26, 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 DREAMSTATION AUTOSV DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED FREQUENT DIZZINESS AND STRONG MUCOUS FORMATION IN THE UPPER RESPIRATORY TRACT, ESPECIALLY IN THE PARANASAL SINUSES AS WELL AS REGULAR EYE IRRITATIONS, ADDITIONALLY PATIENT IS ASSUMING, WHOLE SITUATION CAN CAUSE ENORMOUS PSYCHOLOGICAL STRESS. THERE WAS NO REPORT 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 INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dizziness; Eye Irritation; Unspecified Respiratory Problem

  MAUDE report 18015620 ↗