BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYAIRE AMBU BAG

    MDR report key: 24755293 · Received April 1, 2026

    Report

    Report Number
    MW5186229
    Event Type
    Death
    Date Received
    April 1, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 27, 2026
    Manufacturer
    VYAIRE MEDICAL/ SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AMBU BAG USED DURING CODE BLUE NOTED TO BE DEFECTIVE WITH AN AIR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812907 VYAIRE AMBU BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VYAIRE MEDICAL/ SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE 0004306672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death