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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959031593), received between Mar 16, 2022 and Mar 25, 2026 — 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.

• MalfunctionMar 25, 2026Degraded

  A BIPAP AUTO BIFLEX 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 FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY. IN ADDITION, TOBACCO CONTAMINATION AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688367 ↗
• MalfunctionMar 23, 2026Degraded

  A BIPAP AUTO BIFLEX 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 OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. IN ADDITION, FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY, TOBACCO CONTAMINATION AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663479 ↗
• MalfunctionMar 16, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, CONTAMINATION WAS OBSERVED IN THE BLOWER HOUSING, RIGHT SIDE ASSEMBLY, AIR INLET SEAL, AND THE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777435 ↗