BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA 4C

    MDR report key: 446848 · Received March 5, 2003

    Report

    Report Number
    MW1027738
    Event Type
    Malfunction
    Date Received
    March 5, 2003
    Date of Event
    February 12, 2003
    Report Date
    February 26, 2003
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    1) PT RECEIVED HIGHER IFC INTENSITY AS CHANNEL 1 CONNECTOR TO MACHINE WAS NOT ALL THE WAY IN. OUTPUT WAS STILL BEING DETECTED BY PT - NOTED SHARP STRONG AMP, SUDDENLY, SHORT DURATION AS THERAPIST DECREASED AMP. NO SKIN DISCOLORATION OR APPARENT INJURY. 2) REVIEWED OWNERS MANUAL. NO PRECAUTIONS FOUND AS IT RELATES TO CABLES NOT BEING FULLY CONNECTED. RECOMMEND REVIEW BY MANUF. AND/OR DESIGN EQUIPMENT TO NOT WORK WHEN CONNECTOR IS NOT COMPLETELY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA 4C ULTRASOUND E-STIM THERAPY IMG CHATTANOOGA GROUP, INC. VECTRA 4C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other