DreamStation DreamStation CPAP Pro, GBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959023482), received between Nov 30, 2018 and Mar 23, 2026 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Degraded

  A DREAMSTATION CPAP PRO 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 VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659509 ↗
• MalfunctionMar 19, 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 SPITTING OUT BLACK FOAM AND NOTICED IT DUE TO COLLECTION OF FOAM PARTICLES WITHIN THE HUMIDIFIER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE NOT OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED, AND THE DEVICE WAS CORRECTED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647128 ↗
• InjuryNov 4, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Abdominal Distention; Back pain; Burning Sensation; Choking; Cough; Dyspnea; Fatigue; Headache; Hearing Impairment; Heart Failure/Congestive Heart Failure; Hypokalemia; No Clinical Signs, Symptoms or Conditions; Pelvic Pain; Sinusitis; Skin Inflammation/ Irritation; Sore Throat; Swelling/ Edema; Unspecified Blood or Lymphatic problem; Unspecified Eye / Vision Problem

  MAUDE report 12754734 ↗
• DeathNov 30, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF A PATIENT DEATH. A FAMILY MEMBER IS ALLEGING THAT THE CONTINUOUS POSITIVE AIRWARE PRESSURE (CPAP) DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE DATE OF DEATH IS UNKNOWN AND THERE HAS BEEN NO OTHER INFORMATION PROVIDED TO DATE. IT IS UNKNOWN IF THE PATIENT WAS WEARING THE CPAP DEVICE AT THE TIME OF DEATH. THE INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Death

  MAUDE report 8120172 ↗