BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 357496 · Received October 20, 2001

    Report

    Report Number
    1821850-2001-00007
    Event Type
    Malfunction
    Date Received
    October 20, 2001
    Date of Event
    March 23, 1999
    Report Date
    October 18, 2001
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING CARDIOPULMONARY RESUSCITATION ON A PATIENT, THE PARAMEDIC ON THE SCENE REPORTED THAT THE COMPRESSION TO VENTILATION RATIO CHANGED FROM 5:1 TO 4:1. PARAMEDIC REPORTED THAT THE PATIENT WAS CODED BLUE AND HAD DIED BEFORE THEIR ARRIVAL ON THE SCENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47231 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR