BEUDAMED
    FDA Adverse Event Other Summary report: N

    TM-2100

    MDR report key: 1200392 · Received October 16, 2008

    Report

    Report Number
    9613557-2008-00008
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 16, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    IOL
    PMA / PMN Number
    K802836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STRESS TEST, THE TREADMILL ALLEGEDLY WENT FROM STEP 1 TO STEP 5 WITHOUT USER COMMAND. THE PATIENT FELL DOWN ON THE WALKING BELT BEFORE THE EMERGENCY STOP WAS ACTIVATED. THE PATIENT'S MASK AND ELECTRODES WERE PULLED OFF DURING THE FALL. THE PATIENT SUSTAINED SUPERFICIAL BURNS ON HER ELBOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM-2100 TREADMILL IOL GE HEALTHCARE T2100ACB

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR