BEUDAMED
    FDA Adverse Event Death Summary report: N

    QAMBU

    MDR report key: 488355 · Received October 7, 2003

    Report

    Report Number
    488355
    Event Type
    Death
    Date Received
    October 7, 2003
    Date of Event
    September 25, 2003
    Report Date
    October 7, 2003
    Manufacturer
    AMBU, INC
    Product Code
    BTM
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FOUND UNRESPONSIVE IN BACKYARD, BROUGHT IN BY EMS. UPON ARRIVAL TO ER, NO BREATH SOUNDS WERE AUDIBLE, NO CHEST RISE WAS SEEN WITH BAGGING. STAFF FELT AMBUBAG NOT FUNCTIONING PROPERLY AND REPLACED. AFTER NEW BAG, PT HAD BILATERAL. AFTER NEW BAG, PT HAD BILATERAL BREATH SOUNDS. PT PRONOUNCED DEAD AT 1612. AIR SEAL ON BOTTOM OF AMBUBAG IS SECURED BY 4 STAPLES. FAILURE OF ANY STAPLE WILL CAUSE AIR TO LEAK. EXAMINATION OF BAG REVEALED ONE STAPLE MAY NOT HAVE BEEN SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QAMBU AMBU SPUR, ADULT RESUSCITATOR BTM AMBU, INC 534509 61750

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death