BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAG EASY RESUSCITATOR

    MDR report key: 7537292 · Received May 23, 2018

    Report

    Report Number
    MW5077413
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 21, 2018
    Manufacturer
    WESTMED INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING RESUSCITATED. DURING DEFIBRILLATION, THE DEFIB PADS ARCHED CREATING A SPARK. THE SPARK IGNITED THE RESUSCITATION (AMBU) BAG AND CAUSED A FIRE. THE STAFF QUICKLY REMOVED THE PRODUCT FROM THE PT TO THE FLOOR AND PUT OUT THE FIRE. THIS CREATED BURNS TO THE PT'S RIGHT CHEST/ARM AND FACE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378962 BAG EASY RESUSCITATOR BAG EASY RESUSCITATOR BTM WESTMED INC. 033018U15
    378963 ONESTEP CPR COMPLETE ONESTEP CPR COMPLETE LIX ZOLL MEDICAL CORPORATION 1718C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other