BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 3424418 · Received September 17, 2013

    Report

    Report Number
    3424418
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 17, 2013
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE BECAME AWARE OF AN ISSUE BY A SYSTEM HOSPITAL THAT THEY FOUND A "DUCK VALVE" THAT GOT STUCK WHILE TRYING TO USE A RESUSCITATION BAG VALVE MASK- WE CHECKED OUR SUPPLIES AND FOUND 28 DEFECTIVE VALVES. WITH SOME EXTRA PRESSURE THE VALVE WILL RELEASE, BUT IN A CODE SITUATION THESE VALVES COULD POSE A RISK. LOTS INVOLVED INCLUDED LOT # 106564 MANUFACTURED 3/13; LOT # 106003 MANUFACTURED 2/13; LOT # 105157 MANUFACTURED 1/13; LOT # 107509 MANUFACTURED 5/13; LOT # 99301 MANUFACTURED 1/13; LOT # 101304 MANUFACTURED 5/12; LOT # 98820 MANUFACTURED 12/11; LOT # 86341 MANUFACTURED 12/09; LOT # 85521 MANUFACTURED 11/09; LOT # 83709 MANUFACTURED 8/09; LOT # 79475 MANUFACTURED 12/08 AND LOT # 76380 MANUFACTURED 8/08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468840 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 106564
    468841 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 106003
    468842 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 105157
    468843 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 107509
    468844 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 99301
    468845 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 101304
    468846 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 98820
    468847 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 86341
    468848 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 85521
    468849 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 83709
    468850 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 76380
    468982 AIRFLOW VENTILATOR, EMERGENCY, MANUAL BTM VENTLAB CORPORATION AF1000 79475

    Patients

    Seq Age Sex Outcome Treatment
    1 *