AF541 AF541 Mask EE, Leak 1, w/ 4 Point Headgear, SmallRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959024366), received between Mar 18, 2021 and Mar 18, 2021 — classified as 3 injuries.

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

• InjuryMar 18, 2021Disconnection; Mechanical Problem; Unintended Movement; Disconnection; Mechanical Problem; Unintended Movement

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE A PATIENT WAS CONNECTED TO A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE, THE MASK BECAME DISCONNECTED FROM THE CIRCUIT AND THE PATIENT BECAME UNRESPONSIVE AND HYPOXEMIC. THE PATIENT SUBSEQUENTLY REQUIRED MANUAL RESUSCITATION WITH AN AMBU BAG TO CORRECT THE HYPOXEMIA. THE MASK IS NOT AVAILABLE FOR INVESTIGATION. THE MASK WAS DISCARDED BY THE FACILITY. NO LOT NUMBER WAS PROVIDED. THE MANUFACTURER IS UNABLE TO DETERMINE IF A FAULT WITH THE MASK CAUSED OR CONTRIBUTED TO THE EVENT. 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 IS CONTRAINDICATED IN 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. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY

  Patient problems: Hypoxia

  MAUDE report 11517379 ↗
• InjuryMar 18, 2021Disconnection; Mechanical Problem; Unintended Movement; Disconnection; Mechanical Problem; Unintended Movement

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE A PATIENT WAS CONNECTED TO A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE, THE MASK BECAME DISCONNECTED FROM THE CIRCUIT AND THE PATIENT BECAME UNRESPONSIVE AND HYPOXEMIC. THE PATIENT SUBSEQUENTLY REQUIRED MANUAL RESUSCITATION WITH AN AMBU BAG TO CORRECT THE HYPOXEMIA. NO DATE OF EVENT WAS PROVIDED. THE MASK IS NOT AVAILABLE FOR INVESTIGATION. THE MASK WAS DISCARDED BY THE FACILITY. NO LOT NUMBER WAS PROVIDED. THE MANUFACTURER IS UNABLE TO DETERMINE IF A FAULT WITH THE MASK CAUSED OR CONTRIBUTED TO THE EVENT. 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 IS CONTRAINDICATED IN 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. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: Hypoxia

  MAUDE report 11517374 ↗
• InjuryMar 18, 2021Disconnection; Mechanical Problem; Unintended Movement; Disconnection; Mechanical Problem; Unintended Movement

  THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION THAT A PATIENT WITH A MEDICAL HISTORY OF SPASTIC QUADRIPLEGIC CEREBRAL PALSY AND EPILEPSY HAD A SPASTIC MOVEMENT WHILE NON- INVASIVE VENTILATION (NIV) AND THE AF541 MASK WERE IN USE, WHICH CAUSED DISCONNECTION BETWEEN THE MASK AND THE CIRCUIT, AND CYANOSIS WITH SUBSEQUENT LOW OXYGEN SATURATION LEVELS. THE PATIENT REQUIRED BAGGING WITH 100% OXYGEN TO RESTORE THE OXYGEN SATURATION TO AN ACCEPTABLE LEVEL, AND NIV WITH THE MASK WAS REINSTITUTED. THE PATIENT WAS COVID+, AND WAS IN AN ISOLATION ROOM. THERE WAS NO SERIOUS OR PERMANENT INJURY. THE DATE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED BY THE REPORTING FACILITY. THE MASK WAS DISCARDED BY THE FACILITY. NO LOT NUMBER WAS PROVIDED. THE MANUFACTURER IS UNABLE TO DETERMINE A FAULT WITH THE MASK CAUSED OR CONTRIBUTED TO THE EVENT. 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 (>(B)(6)) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THIS MASK IS CONTRAINDICATED IN PATIENTS WHO NEED LIFE SUPPORT VENTI

  Patient problems: Hypoxia

  MAUDE report 11517153 ↗