BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRLIFE

    MDR report key: 225739 · Received June 4, 1999

    Report

    Report Number
    225739
    Event Type
    Death
    Date Received
    June 4, 1999
    Date of Event
    May 13, 1999
    Report Date
    June 4, 1999
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING PT FOR TRANSPORT TO OR FOR SURGERY, PT WAS REMOVED FROM VENTILATOR AND ATTACHED TO AMBU BAG. PT WAS BEING VENTILATED MANUALLY, HOWEVER, VENTILATION WAS DIFFICULT. PT BECAME BRADYCARDIC AND DECLINING STATUS WAS BEING ASSESSED. IMMEDIATE ASSISTANCE WAS REQUESTED. RESPIRATORY THERAPIST RESPONDED AND FOUND THAT THE EXHALATION VALVE ON THE AMBU BAG WAS STUCK SHUT, POSSIBLY DUE TO DRIED MUCOUS SECRETIONS. A SPARE DEVICE WAS READILY AVAILABLE AND SUBSTITUTED. PT WAS GIVEN INTERCARDIAC EPINEPHRINE INJECTIONS BUT THIS FAILED TO REINSTATE ANY SPONTANEOUS CARDIAC ACTIVITY. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE ADULT MANUAL RESUSCITATOR BTM ALLEGIANCE HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death