BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATOR BAG

    MDR report key: 2841497 · Received October 3, 2012

    Report

    Report Number
    2246980-2012-00013
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IT IS OUR UNDERSTANDING THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER INVOLVED IS CURRENTLY UNDER A VOLUNTARY RECALL. THE RESULTS OF THE EVALUATION FOUND THAT THE GAS VOLUME FROM THE RESUSCITATOR, WHEN THE BAG WAS COMPRESSED, WAS LEAKING AROUND THE INLET VALVE. THE INLET VALVE IS DESIGNED TO CLOSE AND SEAL WHEN THE BAG IS COMPRESSED AND OPENS ALLOWING GAS TO RE-ENTER THE BAG AFTER A BAG COMPRESSION, ALSO KNOWN AS BAG RECOIL. IT WAS FOUND THAT DELIVERED VOLUME WAS DEPENDENT UPON TECHNIQUE OF BAG COMPRESSION. DEPENDING UPON THE TECHNIQUE USED, SUITABLE VOLUME COULD BE DELIVERED AND ANOTHER TECHNIQUE WOULD PRODUCE LESS THAN THE EXPECTED VOLUME DELIVERY. FURTHER INVESTIGATION OF THE INLET VALVE FOUND THAT IT DID NOT MEET THE SPECIFICATIONS FOR THAT LOCATION OF THE VALVE.

    Description of Event or Problem · 1

    DUE TO THE COMPRESSION OF THE RESUSCITATOR BAG, GAS WAS LEAKING AROUND THE INLET VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRFLOW RESUSCITATOR BAG RESUS BAG BTM VENTLAB CORPORATION 102126

    Patients

    Seq Age Sex Outcome Treatment
    1