BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿

    MDR report key: 12467023 · Received September 14, 2021

    Report

    Report Number
    12467023
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    June 24, 2021
    Report Date
    September 13, 2021
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MANOMETER ON VYAIRE MEDICAL AIRLIFE INFANT MANUAL RESUSCITATOR WAS STUCK NOT ALLOWING THE BAG TO REFILL PROPERLY. BAGS REMOVED FROM SERVICE AND TESTED AND THEY APPEARED TO BE IN WORKING CONDITION DURING TESTING OVER SEVERAL MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363265 AIRLIFE¿ VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM 0004179972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other