BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISEN STAR TRAK

    MDR report key: 314777 · Received February 2, 2001

    Report

    Report Number
    314777
    Event Type
    Injury
    Date Received
    February 2, 2001
    Date of Event
    December 12, 2000
    Report Date
    January 16, 2001
    Manufacturer
    UNISEN, INC
    Product Code
    IOL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    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 POST EVENT WHILE AT HOME. FOLLOWING THE EVENT, THE FACILITY DISCUSSED SITUATION WITH THE VENDOR AND MODIFIED DISPLAY/CONTROL PANELS. GIVEN THE AGE OF FACILITY'S PT POPULATION, IT IS BELIEVED THAT THE PT INJURY MAY BE A RESULT OF PRODUCT DESIGN RATHER THAN A DEFECT IN THE EQUIPMENT WHICH EASILY LED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4085 UNISEN STAR TRAK TREADMILL IOL UNISEN, INC STAR TRAK 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R