BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT MOBILE COMBO

    MDR report key: 1180925 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00231
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    December 12, 2006
    Report Date
    December 12, 2006
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Removal / Correction Number
    1022819-2008-00231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR EXPORT ONLY. EVALUATION RESULTS: DURING SOFTWARE UPDATE TO THE STIMULATOR BOARD CHANNEL #1 FAILED. COMPLETED A POWER UP TEST, AND REPLACED STIM BOARDS. REPLACED ULTRASOUND CRYSTAL ON APPLICATOR AND RECALIBRATED DUE TO COSMETIC ISSUES. GENERAL UPDATES TO SOFTWARE; CONTROL BOARD 2.3, STIMULATOR BOARD 2.3, GENERATOR BOARD 2.5.

    Description of Event or Problem · 1

    CUSTOMER PURCHASED AN INTELECT MOBILE COMBO. WHEN USED ON THE PATIENT, IT GIVES SHOCKS WHEN THE INTENSITY IS LOW. 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 MOBILE COMBO IPF, IMG, GZJ, GZI IPF CHATTANOOGA GROUP 2778

    Patients

    Seq Age Sex Outcome Treatment
    1