DreamStation DreamStation Auto CPAP, BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959027343), received between Aug 17, 2021 and Oct 7, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Degraded; No Apparent Adverse Event; Degraded; No Apparent Adverse Event

  THIS REPORT IS BEING SUBMITTED TO CORRECT THE DESCRIPTION OF THE EVENT OR PROBLEM PREVIOUSLY REPORTED. THE DREAMSTATION AUTO CPAP WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE PRIOR TO THE COMPLAINT ON 06/29/2022. THE DEVICE WAS CORRECTED, AND SOUND ABATEMENT FOAM REPLACEMENT OCCURRED. THE DEVICE DOES NOT FALL UNDER THE RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM. FURTHERMORE, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MALFUNCTIONED IN A WAY THAT COULD LEAD TO DEATH OR SERIOUS INJURY IF THE ISSUE WERE TO RECUR. THEREFORE, THIS COMPLAINT IS NOT REPORTABLE TO ANY REGULATORY AGENCIES.

  Patient problems: Anxiety; Cough

  MAUDE report 20389601 ↗
• MalfunctionAug 14, 2024Degraded; Degraded

  LEGAL BENELUX TEAM HAS RECEIVED ON (B)(6) 2024 FURTHER INFORMATION FROM THE ATTORNEY REGARDING THE PATIENT'S COMPLAINT. THE LAWYER HAS CLARIFIED THE SERIAL NUMBER OF THEIR CLIENT'S DREAMSTATION DEVICE. AND HAS ALSO INFORMED THAT THE PATIENT WOULD LIKE TO KEEP THE DEVICE AND IS CONTEMPLATING STARTING LEGAL EXPERT PROCEEDINGS. THE DEVICE WON¿T BE RETURNING TO THE MANUFACTURER FOR FURTHER EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 19985191 ↗
• MalfunctionAug 17, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG CANCER. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF A SURGERY FOR TUMOR REMOVAL. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333162 ↗