BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 503138 · Received December 5, 2003

    Report

    Report Number
    1821850-2003-00009
    Event Type
    Malfunction
    Date Received
    December 5, 2003
    Date of Event
    November 23, 2003
    Report Date
    December 3, 2003
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS BEING USED TO ASSIST A PATIENT IN CARDIAC ARREST, COMPRESSIONS WERE PERFORMED FOR SEVERAL MINUTES AND THE UNIT WAS TURNED OFF. WHEN AN ATTEMPT WAS MADE TO TURN THE UNIT BACK ON IT STOPPED CYCLING. THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR CONTINUED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR