BEUDAMED
    FDA Adverse Event Death Summary report: N

    THUMPER BOARD

    MDR report key: 533010 · Received June 28, 2004

    Report

    Report Number
    1821850-2004-00008
    Event Type
    Death
    Date Received
    June 28, 2004
    Date of Event
    June 9, 2004
    Report Date
    June 25, 2004
    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

    DURING OPERATION OF THE THUMPER CPR, CUSTOMER NOTED SHIFTING OF THE THUMPER IN RELATION TO PT. CUSTOMER REMOVED THE DEVICE FROM THE PT AND CONTINUED MANUAL CPR. CUSTOMER CITED BOARD WELDS AS REASON FOR DEVICE SHIFTING ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER BOARD RESTRAINT DEVICE FOR MECHANICAL/MANUAL CPR DRM MICHIGAN INSTRUMENTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death