BEUDAMED
    FDA Adverse Event Death Summary report: N

    THUMPER

    MDR report key: 150228 · Received February 18, 1998

    Report

    Report Number
    1821850-1998-00001
    Event Type
    Death
    Date Received
    February 18, 1998
    Date of Event
    January 10, 1998
    Report Date
    February 18, 1998
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THUMPER SYSTEM AFTER BEING APPLIED TO THE PT, GRADUALLY SLOWED DOWN AND VENTILATION TIMES INCREASED. THE UNIT WAS BEING APPLIED TO A PT IN A STATE OF CLINICAL DEATH TO PROVIDE CPR SUPPORT. THE DEVICE WAS REMOVED FROM THE PT AND MANUAL CPR WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER MECHANICAL CARDIOPULMANARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1004/1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death