BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDELINE 4000

    MDR report key: 1765612 · Received July 6, 2010

    Report

    Report Number
    3005677147-2010-00005
    Event Type
    Malfunction
    Date Received
    July 6, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K071364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE PRODUCT WAS PERFORMED ON SITE BY FHC TECHNICAL SUPPORT PERSONNEL WHO WAS ABLE TO CHECK THE IMPEDANCE ON ALL CHANNELS AND REPORTED THAT MEASUREMENTS WERE COMING IN CORRECTLY. IT WAS FOUND UPON BOOTING UP THE GL4K THAT IT WAS SET TO THE FACTORY DEFAULT SETTINGS WHICH SUBSEQUENTLY CHANGED THE PRODUCT DISPLAYS, WHICH WERE INTERPRETED AS AN ERROR. THE RETURN TO DEFAULTS COULD ALSO HAVE BEEN RESPONSIBLE FOR THE CONTROLLER PROBLEMS. THE FIRMWARE ON THE BOARDS IS NOW CORRECT, AS THE FIRMWARE ERROR MESSAGES COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    CUSTOMER HAD REPORTED TO FHC SALESPERSON AND SUBSEQUENTLY TO FHC PRODUCT MGR THAT DURING A SURGERY ON (B)(6), 2010, HIS MICROTARGETING CONTROLLER (MTC) WAS NOT BEING DETECTED BY THE GUIDELINE 4000 (GL4K) ("MTC NOT DETECTED" ERROR ON THE ELECTRODE TAB), AND THAT ALTHOUGH HE HAD THREE CHANNELS ACTIVE (GREEN LEDS), ONLY ONE CHANNEL WAS TRANSMITTING DATA (ON SCREEN). SURGERY WAS CANCELLED AFTER THE BURR HOLE HAD BEEN OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDELINE 4000 GUIDELINE 4000 GZL FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 66-EL-MS (CONTROLLER)