BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR-8500

    MDR report key: 530601 · Received May 21, 2004

    Report

    Report Number
    530601
    Event Type
    Malfunction
    Date Received
    May 21, 2004
    Date of Event
    May 5, 2004
    Report Date
    May 13, 2004
    Manufacturer
    LIFE FITNESS, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS INSTRUCTED ON USE OF TREADMILL. PT WALKED 3 MINUTES AT 5 MPH (MILES PER HOUR). CARDIO PULMONARY STAFF PRESSED THE CLEAR/PAUSE BUTTON ON THE TREADMILL CONTROL PANEL AND THE TREADMILL CAME TO A STOP. PT'S BLOOD PRESSURE WAS TAKEN AND THE TREADMILL START BUTTON WAS PRESSED TO CONTINUE THE ADDITIONAL 2 PRESET MINUTES. THE PT FINISHED THE ADDITIONAL 2 MINS AT 5 MPH AND THE TREADMILL AUTOMATICALLY WENT INTO COOL DOWN MODE WHICH IS A SLOWER PACE. AT THIS TIME THE CARDIO PULMONARY STAFF PRESSED THE CLEAR/PAUSE BUTTON TO STOP THE BELT. THE TREADMILL MADE A LOUD NOISE AND INCREASED IN SPEED SUDDENLY. THIS CAUSED THE PT TO LOOSE BALANCE AND FALL. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION-THAT IS, THE DEVICE DID NOT DO WHAT IS WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TR-8500 TREADMILL IOL LIFE FITNESS, INC. TR-8500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other