BiPAP System One 60 Series BiPAP Auto BiFlex, 60 Series, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959031722), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Degraded; Degraded

  THIS COMPLAINT HAS BEEN REVIEWED, AND IT HAS BEEN DETERMINED THAT THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. THE EVALUATION RESULT FOUND EXIST CONTAMINATION OF FOAM PARTICLES INSIDE THE BLOWER KIT. THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, HOWEVER THE REPORTED ISSUE/EVENT IS REPORTABLE DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IDENTIFIED IN CAPA PR7211, IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539337 ↗