BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 522960 · Received February 9, 2004

    Report

    Report Number
    1821850-2004-00003
    Event Type
    Malfunction
    Date Received
    February 9, 2004
    Date of Event
    January 8, 2004
    Report Date
    February 6, 2004
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS BEING USED TO PROVIDE CPR SUPPORT FOR A CARDIAC ARREST PT. AFTER 10 MINUTES OF USE, IT WAS REPORTED THAT THE COMPRESSION TO VENTILATION RATIO CHANGED RANDOMLY. THE DEVICE WAS REMOVED AND MANUAL CPR CONTINUED ON THE PT.

    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 25 YR