BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR FLOW RESUS BAG

    MDR report key: 2613671 · Received June 7, 2012

    Report

    Report Number
    2246980-2012-00004
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 25, 2012
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE RETURNED SAMPLE, IT WAS FOUND THAT THE LOCKING C-RING WAS MISSING AND THEREFORE, COULD NOT BE EVALUATED TO DETERMINE WHETHER OR NOT IT WAS DEFECTIVE AND/OR PROPERLY INSTALLED. ATTEMPTS WERE MADE TO RETRIEVE THE LOT NUMBER BUT TO-DATE THERE HAS BEEN NO RESPONSE. RESULTS WERE INCONCLUSIVE AT THIS TIME.

    Description of Event or Problem · 1

    DEVICE WAS ATTACHED TO A RESQPOD DURING A CARDIAC ARREST. WHEN THE CREW MEMBER WENT TO REMOVE THE BVM FROM THE RESQPOD, THE VALVE STEM POPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR FLOW RESUS BAG RESUS BAG BTM VENTLAB CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1