BEUDAMED
    FDA Adverse Event Summary report: N

    STARTRACK-UNISEN INC

    MDR report key: 110592 · Received July 10, 1997

    Report

    Report Number
    110592
    Date Received
    July 10, 1997
    Date of Event
    February 13, 1997
    Report Date
    February 17, 1997
    Manufacturer
    STAR TRAC
    Product Code
    IOL
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT WAS USING TREADMILL AND FELT IT JERK SLIGHTLY. 30 SECONDS LATER, THE TREADMILL WENT TO ITS MAXIMUM SPEED WITHOUT WARNING. THE REHABILITATION TECH ATTEMPTED TO SHUT THE MACHINE OFF, BUT EMERGENCY CORD AND OFF BUTTON DID NOT WORK. THE TREADMILL FINALLY SHUT IT SELF OFF WITHIN 30 SECONDS AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTRACK-UNISEN INC TREADMILL #900 IOL STAR TRAC 900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR