Vital Signs™ AMY520X4F (UDI 10889483596258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483596258), received between Aug 29, 2025 and Aug 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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.

• MalfunctionAug 29, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THERE HAVE BEEN A FEW INSTANCES WHERE THE PATIENT SHOWED HIGH PEEP WITH LOW TIDAL VOLUME, MAKING IT DIFFICULT FOR PRACTITIONERS TO PROPERLY VENTILATE THE PATIENT. IN SOME CASES, THEY REMOVED THE CIRCUIT AND USED AN AMBU BAG, SUCCESSFULLY VENTILATING THE PATIENT. THE HME OCCLUDED DURING USE AND DID NOT ALLOW ANY AIR TO PASS THROUGH IT. THE HME BECAME A BRICK WALL AT THE FILTER. WHILE THERE WAS NO REPORTED INJURY TO THE PATIENT IF IT WERE TO REOCCUR, THERE IS A POSSIBILITY OF SERIOUS HARM OR INJURY TO THE PATIENT AND A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929347 ↗