BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V CARE ADULT RESUSCITATOR

    MDR report key: 1021947 · Received March 28, 2008

    Report

    Report Number
    2246980-2008-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 27, 2008
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    PMA / PMN Number
    K953546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INITIAL OBSERVATION, THE BAG WAS NOT FUNCTIONING PROPERLY. WHEN SQUEEZED, AIR WOULD TRAVEL BACK THROUGH THE TAIL ASSEMBLY. FURTHER EVALUATION REVEALED THAT THE TAIL ASSEMBLY WAS NOT ATTACHED PROPERLY, WHICH COULD MEAN THAT IT HAD BEEN DISASSEMBLED. THIS WAS CONFIRMED IN INITIAL REPORTING BY THE DISTRIBUTOR REPRESENTATIVE. ONCE REMOVED, THE TAIL ASSEMBLY REVEALED THAT THE VALVE HOUSING CONTAINED ;NO ONE-WAY DIAPHRAGM VALVE. THE DIAPHRAGM VALVE IS INSTALLED ON THE INSIDE OF THE BAG. NO VALVE WAS PRESENT.

    Description of Event or Problem · 1

    BAG FAILED TO OPERATE DURING A CODE. THE RT SAID THE BAG JUST WOULD NOT PUSH ANY AIR INTO THE PATIENT. HE QUICKLY FIGURED, IT WAS SOMETHING IN THE REAR OF THE BAG AT THE OXYGEN INTAKE POINT, AND HE JUST SQUEEZED THE CORRUGATED TUBING SHUT AND WAS ABLE TO DELIVER SOMETHING OF A BREATH UNTIL SOMEONE WENT AND GRABBED ANOTHER BAG. LATER HE DISASSEMBLED THE REAR AND FOUND THAT THE REAR INTAKE ONE-WAY VALVE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V CARE ADULT RESUSCITATOR EMERGENCY MANUAL RESUSCITATOR BTM VENTLAB CORPORATION VN1000MX 69989

    Patients

    Seq Age Sex Outcome Treatment
    1