BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU BAG

    MDR report key: 33882 · Received July 2, 1996

    Report

    Report Number
    MW1009419
    Event Type
    Malfunction
    Date Received
    July 2, 1996
    Date of Event
    June 25, 1996
    Report Date
    July 1, 1996
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PT TRANSPORT FROM THE OR TO THE ICU, WHILE THE PT WAS BEING MANUALLY VENTILATED USING A BAG, THE REAR ASSEMBLY THAT CONNECTS TO O2 RESERVOIR FELL OFF THE BAG. VENDOR WAS BROUGHT IN TO DISCUSS PROBLEM, WHERE OTHER BAGS OF SAME LOT ALSO FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU BAG ADULT MANUAL RESUSCITATOR BTM AMBU, INC. 209521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA