DreamStation DreamStation CPAP w/Humidifier, w/WiFi, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959034051), received between Sep 10, 2024 and May 22, 2025 — classified as 2 injuries.

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.

• InjuryMay 22, 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 DREAMSTATION CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED EYE IRRITATION, NOSE IRRITATION, NAUSEA / VOMITING, ASTHMA (NEW OR WORSENING), LUNG DISEASE, PNEUMONIA AND BLOOD CLOT IN LUNGS. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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: Asthma; Eye Irritation; Nausea; Pneumonia; Pulmonary Embolism; Unspecified Respiratory Problem; Vomiting

  MAUDE report 22070466 ↗
• InjurySep 10, 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 RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, BREAST CANCER. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. 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: Breast Cancer; Dizziness; Headache; Unspecified Respiratory Problem

  MAUDE report 20186592 ↗