BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 375840 · Received February 1, 2002

    Report

    Report Number
    1821850-2002-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2002
    Date of Event
    November 2, 2001
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON ARRIVAL AT THE SCENE OF A CARDIAC ARREST, THE THUMPER CARDIOPULMONARY RESUSCITATOR WAS APPLIED TO THE PATIENT. IT WAS REPORTED THAT THE DEVICE WOULD NOT PERFORM COMPRESSIONS. THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR CONTINUED. THE PATIENT HAD BEEN IN CARDIAC ARREST FOR 45 MINUTES PRIOR TO THE ARRIVAL OF AMBULANCE AND THE ATTEMPTED RESUSCITATION.

    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 70 YR