BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRLIFE/ALLEGIANCE ADULT MANUAL RESUSCITATOR

    MDR report key: 214706 · Received March 3, 1999

    Report

    Report Number
    214706
    Event Type
    Death
    Date Received
    March 3, 1999
    Date of Event
    January 29, 1999
    Report Date
    March 3, 1999
    Manufacturer
    ENGINEERED MEDICAL SYSTEMS
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING TAKEN TO OR FOR TRACH PROCEDURE. RESPIRATORY THERAPIST WAS USING HAND-HELD AMBU BAG ON PATIENT. THE AMBU BAG WAS DIFFICULT TO USE; PATIENT WAS OBVIOUSLY IN DISTRESS ON ELEVATOR TRIP DOWN TO O.R. PATIENT WAS "DNR" ("DO NOT RESUSCITATE" STATUS) AND DIED UPON ARRIVAL IN O.R. PATIENT HAD BEEN IN INTENSIVE CARE UNIT FOR SOME TIME AND HAD ARRESTED TWICE PRIOR TO THIS INCIDENT. DEVICE WAS DISCARDED IN O.R. AND WAS NOT PUT ON A "TEST LUNG" TO CHECK THE EXHALATION PASSAGEWAY. NOTE: THE TERM "AMBU BAG" IS USED TO REFER TO A DISPOSABLE MANUAL RESUSCITATOR. NOTE: DUE TO THIS PATIENT'S CONDITION, AND TERMINAL ILLNESS, THIS WAS NOT INVESTIGATED AS A POSSIBLE DEVICE PROBLEM UNTIL ANOTHER SIMILAR EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE/ALLEGIANCE ADULT MANUAL RESUSCITATOR SINGLE PATIENT USE MANUAL RESUSCITATOR BTM ENGINEERED MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death