AF531 AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single UseRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959004566), received between Oct 13, 2017 and Oct 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 13, 2017Break; Detachment Of Device Component; Difficult to Remove

  A PATIENT ARRIVED TO THE EMERGENCY CENTER IN PENDING RESPIRATORY FAILURE. SPO2 83% WHILE ON A NRB WITH VERY LABORED BREATHING. THE PHYSICIAN ORDERED BIPAP TO BE STARTED. RESPIRATORY THERAPIST WAS PREPARING TO USE AN 840 VENT WHICH REQUIRES THAT THE ELBOW ATTACHMENT ON THE MASK BE EXCHANGED WITH RESPIRONICS PRODUCT REF: 1043210. THE ELBOW CURRENTLY ON THE MASK COULD NOT BE REMOVED AT ALL. ANOTHER MASK WAS RETRIEVED AND ONCE AGAIN, THAT ELBOW COULD NOT BE REMOVED. IN THE PROCESS OF TRYING TO REMOVE THE ELBOW FROM THE SECOND MASK, THE ELBOW HOLDER PHYSICALLY BROKE OFF OF THE MASK. THERE WAS A LONG DELAY OF CARE AND THE PATIENT FURTHER DESATURATED TO 75% AND BECAME CYANOTIC. A THIRD MASK FUNCTIONED NORMALLY AND THE PATIENT WAS ABLE TO BE PLACED ON BIPAP WITH IMPROVED SATURATION, COLOR, AND WOB. THE TOTAL DELAY TIME WAS 30 MINUTES. UPON FURTHER INVESTIGATION BY THE CLINICAL ENGINEERING DEPARTMENT, IT WAS NOTED BY THE RESPIRATORY THERAPISTS THAT SEVERAL MASKS HAD ELBOW ATTACHMENTS THAT COULD NOT BE REMOVED. 17 MASKS IN TOTAL WERE COLLECTED, INCLUDING THE 2 MASKS FROM THIS EVENT. ALL MASKS WERE PART OF 3 LOT NUMBERS. PER SITE REPORTER: THE SALES REP WILL FILE A COMPLAINT REPORT AND EXCHAN

  Patient problems: Cyanosis; Low Oxygen Saturation

  MAUDE report 6947505 ↗