BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLEGIANCE HEALTH CARE AIRLIFE INTUBATION ADAPTER

    MDR report key: 175456 · Received June 30, 1998

    Report

    Report Number
    175456
    Event Type
    Death
    Date Received
    June 30, 1998
    Date of Event
    June 23, 1998
    Report Date
    June 25, 1998
    Manufacturer
    ALLEGIANCE HEALTH CARE
    Product Code
    BZA
    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

    UNABLE TO VENTILATE PT. THE AIRLIFE INTUBATION ADAPTER USED AS THE CONNECTOR FOR THE CIRCUIT EXTENSION FROM THE VENTILATOR WAS DEFECTIVE. THE ADAPTER WAS FOUND TO HAVE A PLASTIC MEMBRANE TOTALLY OCCLUDING THE AIRFLOW TO THE INLET SIDE OF THE VENTILATOR. PT SUFFERED CEREBRAL ANOXIA WHICH MAY HAVE RESULTED IN PT'S DEMISE. THIS REPORT IS A FOLLOW-UP OF NO. 3902560000-1998-0015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE HEALTH CARE AIRLIFE INTUBATION ADAPTER AIRLIFE INTUBATION ADAPTER BZA ALLEGIANCE HEALTH CARE * Y8C1917

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Death| H| L| O| R| S NARKOMED 2B ANESTHESIA MACHINE.