BEUDAMED
    FDA Adverse Event Other Summary report: N

    THUMPER

    MDR report key: 476095 · Received July 30, 2003

    Report

    Report Number
    1821850-2003-00006
    Event Type
    Other
    Date Received
    July 30, 2003
    Date of Event
    July 10, 2003
    Report Date
    July 29, 2003
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE SCENE OF A CARDIAC ARREST, THE DEVICE WAS BEING PREPARED TO PUT ON THE PATIENT TO PROVIDE CPR. PRIOR TO ITS APPLICATION TO THE PATIENT, IT WAS DISCOVERED THAT UNIT WAS NOT WORKING. MANUAL CPR WAS PERFORMED. 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 NA