AF531 A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959007314), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• MalfunctionMar 17, 2022Use of Device Problem; Use of Device Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT FOLLOWING AN EXTUBATION, IT WAS ALLEGED THAT A COVID POSITIVE PATIENT NEEDED EMERGENCY NIV THERAPY. IT WAS REPORTED THAT THE AF 531 ORAL NASAL MASK AND ELBOW USED WERE CHANGED FROM PREVIOUS MODELS AND NOT COMPATIBLE WITH THE PATIENT'S CIRCUIT. THE CARE PROVIDERS HAD TO USE THE OLDER MASK MODEL OF A SIZE WHICH WAS NOT A GOOD MASK FIT FOR THE PATIENT. THIS ALLEGEDLY CREATED LEAKS, EXPOSED THE MEDICAL STAFF TO POSSIBLE CONTAMINATION AND MADE THE PATIENT'S THERAPY MORE DIFFICULT. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE INVESTIGATION IS ON-GOING. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13801636 ↗