BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR FLOW ADULT RESUSCITATOR

    MDR report key: 3426737 · Received September 6, 2013

    Report

    Report Number
    3426737
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    July 16, 2013
    Report Date
    September 6, 2013
    Manufacturer
    VENTLAB MEDICAL CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING TO PERFORM A PROCEDURE WITH SEDATION, AN AIR FLOW ADULT RESUSCITATOR WAS REMOVED FROM IT'S PROTECTIVE BAG AND AN ATTEMPTED TO TEST IT. IT WAS NOTED THE BAG SECTION OF THE RESUSCITATOR WAS IMPOSSIBLE TO SQUEEZE. THE ONE WAY VALVE WAS STUCK IN THE CLOSED POSITION SO NO AIR COULD BE FORCED THROUGH IT. A SECOND DEVICE WAS OBTAINED AND FAILED AS WELL. A THIRD DEVICE WAS OBTAINED AND IT DID WORK PROPERLY. A SLIGHT DELAY IN STARTING THE PROCEDURE OCCURRED BUT THEN WENT ON WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444024 AIR FLOW ADULT RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VENTLAB MEDICAL CORPORATION AF1140MB 105829
    444184 AIR FLOW ADULT RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VENTLAB MEDICAL CORPORATION AF1140MB 105829

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES