BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 381603 · Received March 6, 2002

    Report

    Report Number
    1821850-2002-00003
    Event Type
    Malfunction
    Date Received
    March 6, 2002
    Date of Event
    February 7, 2002
    Report Date
    March 6, 2002
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    UPON ARRIVAL AT THE SCENE OF A CARDIAC ARREST (ASYSTOLE), THE THUMPER WAS SET UP TO PROVIDE CPR SUPPORT. IT WAS REPORTED THAT THE DEVICE WOULD NOT PERFORM COMPRESSIONS OR VENTILATIONS. THE DEVICE WAS REMOVED AND MANUAL CPR CONTINUED. THE PATIENT WAS NOT REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR