AF541 AF541 Mask EE, Leak 1, with Capstrap, XLarge, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959024434), received between Sep 4, 2020 and Sep 4, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• DeathSep 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH ((B)(4)) IN WHICH IT IS ALLEGED A PATIENT DEATH OCCURRED. A MASK WAS REPORTEDLY IN USE ON THE PATIENT FOR 3 DAYS AT A FACILITY, AND A PRESSURE ULCER DEVELOPED ON THE BRIDGE OF THE PATIENT'S NOSE. THE PRESSURE ULCER WAS TREATED WITH BACITRACIN OINTMENT. THE MANUFACTURER CONTACTED THE REPORTING FACILITY FOR ADDITIONAL INFORMATION. THERE WAS NO DATE OF DEATH PROVIDED, NO CAUSE OF DEATH, AND NO RATIONALE AS TO HOW THE USE OF THE MASK AND SUBSEQUENT DEVELOPMENT OF A PRESSURE ULCER MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THIS MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT ONLY. THE MASK IS TO BE USED ON PATIENTS (>40LBS/20KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THIS MASK SHOULD NOT BE USED ON PATIENTS WHO NEED LIFE SUPPORT VENTILATION, WHO ARE TAKING A PRESCRIPTION DRUG THAT MAY CAUSE VOMITING, OR ON PATIENTS THAT ARE UNCOOPERATIVE, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK BY THEMSELVES. LABELING WARNS THE CAREGIVER TO "MONITOR OR INTERVENE IF THE

  Patient problems: Death

  MAUDE report 10494972 ↗