BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREADMILL

    MDR report key: 33492 · Received June 14, 1996

    Report

    Report Number
    MW1009302
    Event Type
    Injury
    Date Received
    June 14, 1996
    Date of Event
    July 21, 1995
    Report Date
    June 4, 1996
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIRST PT TO USE THE TREADMILL THAT DAY. AS PT WAS WALKING ON TREADMILL, THE BELT STOPPED SUDDENLY AND COMPLETELY. THERE WAS A NOTICEABLE BURNING ODOR, AND AN "OS" CODE WAS SHOWN IN THE SPEED DISPLAY. WHEN ATTEMPTING TO RESTART THE TREADMILL, WHEN START BUTTON WAS PUSHED, THE TREADMILL STARTED UP WITH THE BLET MOVING IMMEDIATELY AT TOP SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREADMILL TREADMILL IOL BIODEX MEDICAL SYSTEMS, INC. 945-200

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention