BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU

    MDR report key: 706286 · Received April 11, 2006

    Report

    Report Number
    MW1038457
    Event Type
    Injury
    Date Received
    April 11, 2006
    Date of Event
    April 2, 2006
    Report Date
    April 10, 2006
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 0

    WHILE USING AN AMBU "MEDIBAG" BAG VALVE MASK THE BAG BECAME PARTIALLY SEPARATED FROM THE HARD PLASTIC BODY AT THE PT END OF THE DEVICE. THIS ALLOWS THE AIR/OXYGEN TO ESCAPE RATHER THAT VENTILATING THE PT. WE HAVE SINCE INSPECTED OUR OTHER DEVICES AND HAVE FOUND TWO MORE THAT HAD SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 AMBU ADULT MEDIBAG W/ MEDIUM ADULT MASK CLOSED RESERVOIR BAG BTM AMBU INC. AMBU MEDIBAG 001716

    Patients

    Seq Age Sex Outcome Treatment
    0 64 YR