BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 509725 · Received January 9, 2004

    Report

    Report Number
    1821850-2004-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    December 8, 2003
    Report Date
    January 9, 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

    THIS UNIT WAS BEING USED TO PERFORM CPR ON A PATIENT IN CARDIAC ARREST. IT WAS REPORTED THAT WHEN THE OXYGEN SOURCE WAS SWITCHED FROM PORTABLE OXYGEN TO THE AMBULANCE OUTLET. THE UNIT WOULD NOT RUN. THE UNIT IMMEDIATELY SWITCHED BACK TO THE PORTABLE SUPPLY AND THE DEVICE AGAIN RAN FINE. PARAMEDICS REPORTED THAT THE PATIENT HAD FULL CPR SUPPORT DURING THE CODE.

    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