BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERADMILL T635M

    MDR report key: 5214083 · Received November 5, 2015

    Report

    Report Number
    MW5057784
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 28, 2015
    Report Date
    November 5, 2015
    Manufacturer
    SPORTSART
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICAL THERAPY STAFF MEMBER HAD A PT RUNNING AT 5.5 MPH ON THE TREADMILL. THE TREADMILL ABRUPTLY STOPPED WITH NO WARNING. THE PT LOST BALANCE DUE TO SUDDEN STOP AND JUMPED OFF BUT WAS NOT INJURED. AFTER APPROX 30 SECONDS THE TREADMILL STARTED UP AGAIN. TREADMILL WAS TAKEN OUT OF SERVICE DUE TO CONCERNS OF RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736950 TERADMILL T635M TERADMILL T635M IOL SPORTSART T635M

    Patients

    Seq Age Sex Outcome Treatment
    1