BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGINEERED MEDICAL SYSTEMS

    MDR report key: 457226 · Received April 29, 2003

    Report

    Report Number
    MW1028290
    Event Type
    Malfunction
    Date Received
    April 29, 2003
    Date of Event
    April 6, 2003
    Report Date
    April 10, 2003
    Manufacturer
    ENGINEERED MEDICAL SYSTEMS
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMBU BAG MALFUNCTIONED WHILE ATTEMPTING TO VENTILATE PT FOLLOWING INTUBATION. AIR HOLE TO O2 CLOSED. NEW AMBU BAG OBTAINED FROM ANOTHER AREA OF ER. NO ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGINEERED MEDICAL SYSTEMS AMBU BAG BTM ENGINEERED MEDICAL SYSTEMS 301-5582 05582021213

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other