BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNISEN STAR TRAK

    MDR report key: 323851 · Received February 20, 2001

    Report

    Report Number
    2027408-2001-00001
    Event Type
    Other
    Date Received
    February 20, 2001
    Date of Event
    December 12, 2000
    Report Date
    January 16, 2001
    Manufacturer
    UNISEN, INC.
    Product Code
    IOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PARTICIPATING IN AN OUTPATIENT PULMONARY REHABILITATION PROGRAM. WHILE WALKING ON THE TREADMILL THE PT ATTEMPTED TO INCREASE THE SPEED FROM 1.6 TO 1.8 MPH. APPARENTLY THE PT ATTEMPTED TO DEPRESS THE #1 ON THE DISPLAY PANEL AND THEN THE #8. INADVERTENTLY NO CONTACT WAS MADE WITH THE NUMBER 1 AND THE SPEED BEGAN RAPIDLY INCREASING TO REACH 8 MPH. THE PT WAS THROWN BACKWARDS OFF THE TREADMILL AND SUSTAINED IN ADDITION TO MULTIPLE ABRASIONS AND BRUISES A LEFT SHOULDER DISLOCATION AND FRACTURE TO THE HUMERAL HEAD. SURGICAL INTERVENTION WAS REQUIRED. THE PT ALSO REQUIRED REHABILITATIVE AND HOME HEALTH SERVICES. ALTHOUGH UNABLE TO DETERMINE IF RELATED TO THE EVENT, THE PT EXPIRED 19 DAYS POST EVENT WHILE AT HOME. FOLLOWING THE EVENT, THE FACILITY DISCUSSED SITUATION WITH THE VENDOR AND MODIFIED DISPLAY/CONTROL PANELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6983 UNISEN STAR TRAK TREADMILL IOL UNISEN, INC. STAR TRAK 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R