BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU/MARK III

    MDR report key: 34364 · Received July 2, 1996

    Report

    Report Number
    34364
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    June 25, 1996
    Report Date
    June 28, 1996
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING TRANSPORTED FROM SURGICAL SUITE TO ICU. ANESTHESIOLOGIST WAS AMBUING PT VIA ENDOTRACHEAL TUBE AND AMBU BAG DISCONNECTED/FELL APART AND UNABLE TO BE USED. ANOTHER HEALTH CARE PROVIDER RAN FOR AND RETRIEVED ANOTHER AMBU BAG FROM ICU. THEREFORE, PT DID NOT SUFFER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU/MARK III RESUSCITATOR BTM AMBU, INC. AMBU RESUSCITATOR 209521

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention