BEUDAMED
    FDA Adverse Event Death Summary report: N

    THUMPER

    MDR report key: 437095 · Received January 10, 2003

    Report

    Report Number
    1821850-2003-00002
    Event Type
    Death
    Date Received
    January 10, 2003
    Date of Event
    July 31, 2001
    Report Date
    January 10, 2003
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A PROBLEM WITH A THUMPER DURING A CARDIAC ARREST RESCUE. THE THUMPER WAS INITIALLY BEING USED FOR COMPRESSIONS ONLY. WHEN THE VENTILATION KNOB WAS TURNED ON, THE COMPRESSION DEPTH BECAME UNSTABLE AND WENT FROM 4 TO 8 CM. THE DEVICE WAS REMOVED FROM THE PT AND MANUAL CPR CONTINUED. THE PT 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