BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT ADVANCED COMBO MONOCHROME

    MDR report key: 1182671 · Received September 25, 2008

    Report

    Report Number
    1022819-2008-00201
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    May 5, 2006
    Report Date
    May 5, 2006
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IMG
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR REPORTED THE DEVICE TO HAVE THE FOLLOWING SOFTWARE VERSIONS: VERSION 3.0, CONTROL 3.0, STIM BOARD1: 2.1, STIM BOARD2: 2.1, ULTRASOUND: 2.3. ALSO THE FOLLOWING PROBLEMS HAVE BEEN REPORTED ON THE SAME PRODUCTS: AGAIN ON CHANNELS 3 AND 4: THE TREATMENT TIME CHANGES TO 90 OR 92 MIN AFTER PRESSING START, AND THE TREATMENT TIME CANNOT BE CHANGED AT THIS MOMENT ( THE TREATMENT TIME WAS ADJUSTED TO 20 MIN. BEFORE PRESSING START BUTTON). WHEN THERE IS AN ONGOING TREATMENT ON CHANNEL 3, IF YOU PRESS HOME BUTTON THEN THE TREATMENT ON THIS CHANNEL STOPS AND ALL BUTTONS ARE LOCKED. THE ONLY THING YOU CAN DO IS TO RESET THE UNIT. WE ASKED THE CUSTOMER NOT TO USE THE CHANNELS 3 AND 4 UNTIL THEY GET A REPLY FROM US. THROUGH EVALUATION 1) AND 2) WAS NOT REPRODUCEABLE. THESE UNITS WERE UPGRADED BY THE DISTRIBUTOR AND WILL NOT BE RETURNED. THE DECISION TO RETAIN THESE UNITS WAS MADE BY THE DISTRIBUTOR. THE DEVICE EVALUATION DETERMINED A MALFUNCTION OF THE MUSCLE STIMULATION PRINTED CIRCUIT BOARD (PART NUMBER 27057). THE DEVICE IS INCLUDED IN THE CORRECTION RECALL REPORTED TO THE FDA. THE MALFUNCTION RESULTS IN AN UNINTENDED OUTPUT DELIVERED TO THE PATIENT'S SKIN BENEATH THE ELECTRODES. IN PARTICULAR MOSFET COMPONENTS FAIL ON THE MUSCLE STIMULATION PRINTED CIRCUIT BOARD AND RESULT IN THE UNINTENDED OUTPUT TO THE PATIENT. THE ENERGY SURROUNDING THE UNINTENDED OUTPUT IS GENERATED WITHIN THE SECONDARY (LOW VOLTAGE) CIRCUITRY. THE PATIENT REMAINS ISOLATED FROM PRIMARY (AC MAINS) CIRCUITRY WHEN THE MALFUNCTION OCCURRED. THE RECALL INCLUDES CORRECTIVE SOFTWARE THAT PREVENTS THE LOW VOLTAGE CIRCUITRY FROM EXPERIENCING THE MALFUNCTION, THUS, AVOIDING DEVICE MALFUNCTION AND ADVERSE EVENTS.

    Description of Event or Problem · 1

    SHOCKING PROBLEM WITH SIX MUSCLE STIMULATION MODULES I.E., CHANNELS 3 AND 4. THE DEVICES ARE SHOCKING PATIENT'S SKIN BENEATH THE ELECTRODES WHEN UTILIZING VARIOUS WAVEFORMS INCLUDING TENS. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PATIENT OUTPUT FROM THE INTENDED OUTPUT TO AN UNINTENDED HIGHER VOLTAGE OUTPUT. WHEN SUCH A MALFUNCTION OCCURS, IT RESULTS IN A SHOCK SENSATION AND POSSIBLE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT ADVANCED COMBO MONOCHROME IMG, GZI, GZJ, HCC, IPF, LIH IMG CHATTANOOGA GROUP 2772MC

    Patients

    Seq Age Sex Outcome Treatment
    1