BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 535667 · Received March 17, 2004

    Report

    Report Number
    1821850-2004-00004
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 17, 2004
    Report Date
    March 17, 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

    THE DEVICE WAS BEING USED ON A PT. IT WAS REPORTED THAT AFTER 30 MINUTES OF USE THE VENTILATIONS AND COMPRESSIONS BECAME RANDOM. THE DEVICE WAS REMOVED FROM PT AND MANUAL CPR CONTINUED.

    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