AF531 AF531 Mask EE, LEAK 1, with CapStrap, Large, Single UseRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959004603), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical 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.

• InjuryMar 15, 2021Mechanical Problem; Mechanical Problem

  THE MANUFACTURER WAS MADE AWARE OF AN EVENT OCCURRING WHILE AN (B)(4) MASK WAS IN USE. A COVID+ PATIENT WAS PLACED ON BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) VENTILATION 2 DAYS BEFORE THE EVENT. THE PATIENT REPORTEDLY ROLLED OVER IN BED, DISLODGING THE MASK FROM THE BIPAP CIRCUIT, AND DECOMPENSATED IMMEDIATELY, RESULTING IN THE NEED FOR BAGGING TO CORRECT HYPOXEMIA. THE MASK WAS THEN RECONNECTED AND NIV WAS REINSTITUTED. THE MASK IS NOT AVAILABLE FOR INVESTIGATION. THE (B)(4) LEAK 1 FACE 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 (>30 KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. LABELING WARNS THE CAREGIVER "THIS MASK IS NOT SUITABLE FOR PROVIDING LIFE SUPPORT VENTILATION. THIS MASK SHOULD NOT BE USED FOR PATIENTS WHO ARE UNCOOPERATIVE, OBTUNDED, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK. APPROPRIATE PATIENT MONITORING SHOULD BE USED AS MEDICALLY NECESSARY. PATIENT, VENTILATOR, AND CIRCUIT MUST BE MONITORED ON A REGULAR BASIS PER ESTABLISHED STANDARDS OF CARE." THE USE OF THIS MASK IS CONTRAINDICATED IN

  Patient problems: Hypoxia

  MAUDE report 11485065 ↗