BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE 400 COMBINATION ELECTRICAL STIMULATION AND ULTRASOUND MACHINE

    MDR report key: 2166644 · Received July 13, 2011

    Report

    Report Number
    MW5021348
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 6, 2011
    Manufacturer
    CHATTANOOGA GROUP INC.
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS TO RECEIVE E STIM TO UPPER LEFT SHOULDER. THE DEVICE WAS TURNED ON AND WAS SENSED BUT IT STOPPED. WHEN TURNED UP ONE NOTCH BY THERAPIST, THE MACHINE DELIVERED A SHOCK TO THE PT. IT WAS REMOVED FROM PT AND SERVICE. THERAPIST THEN USED IT ON HERSELF AND WAS ALSO SHOCKED. NEITHER OF THE SHOCKS WERE SIGNIFICANT AND THERE WERE NO INJURIES. BIOMED STAFF REPORT THE E STIM PORTION OF THE MACHINE TO BE "BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE 400 COMBINATION ELECTRICAL STIMULATION AND ULTRASOUND MACHINE FORTE 400 E STIM IMG CHATTANOOGA GROUP INC. FORTE 400 COMBINATION ELECTRICAL STIMULATION AND ULTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR