BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER-AIRLIFE

    MDR report key: 316500 · Received February 15, 2001

    Report

    Report Number
    MW1021106
    Event Type
    Death
    Date Received
    February 15, 2001
    Date of Event
    February 9, 2001
    Report Date
    February 13, 2001
    Manufacturer
    ALLEGIANCE
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ARREST (CODE) A PT WAS UNABLE TO BE VENTILATED DUE TO AN AMBU BAG THAT COULD NOT BE COMPRESSED. EXAMINATION OF THE DEVICE REVEALED DUCKBILL VALVE (ONEWAY) INSIDE OF HEAD OF BAG WAS NOT PERFORATED. NOT ALLOWING COMPRESSION OF BAG OR AIRFLOW TO REACH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6067 BAXTER-AIRLIFE ADULT MANUAL RESUSITATOR BTM ALLEGIANCE * Y0J0133

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death