BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800 FLUOROTRAK, IT3500 SPINE

    MDR report key: 651788 · Received November 30, 2005

    Report

    Report Number
    1720753-2005-00008
    Event Type
    Malfunction
    Date Received
    November 30, 2005
    Date of Event
    October 31, 2005
    Report Date
    November 30, 2005
    Manufacturer
    GE HEALTHCARE
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING MFG TESTING, IT WAS REPORTED THAT A CHANGE IN THE C-ARM IMAGE INTENSIFIER INTRODUCED IN 2005 HAD IMPACTED THE DISTORTION MAPPING PROCESS OF THE 9" CALIBRATION FIXTURE (P/N 1007911-NAV). THE CALIBRATION FIXTURE IS USED BY THE FLUOROTRAK NAVIGATION APPLICATION TO REGISTER THE X-RAY IMAGE WITH RESPECT TO THE PT'S ANATOMY. THIS IS THE FIRST TIME THIS ISSUE HAS BEEN REPORTED, A PT WAS NOT INVOLVED, AND NO INJURY WAS REPORTED. THE CONCERN IS FOR THE DEGRADATION OF THE NAVIGATION TRACKING ACCURACY WITHIN THE SURGICAL VOLUME AND THE POTENTIAL FOR PT INJURY DURING INVASIVE PROCEDURES.

    Description of Event or Problem · 1

    WE REPORTED IN OUR INITIAL MDR THAT THIS ISSUE AFFECTED ONLY SYSTEMS WITH THE 9" CALIBRATION FIXTURE. WE HAVE SINCE DISCOVERED THAT THE 12" CALIBRATION FIXTURE (P/N 1003587-NAV) IS ALSO AFFECTED. THERE HAS ONLY BEEN ONE AFFECTED 12" 9800 FLUOROTRAK SHIPPED. THIS SITE IS BEING ISSUED A CUSTOMER SAFETY COMMUNICATION, WARNING OF THIS ISSUE, AND REQUESTING THEM TO DISCONTINUE USE UNTIL A SOLUTION IS INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROTRAK, IT3500 SPINE SURGICAL NAVIGATION SYSTEM JAA GE HEALTHCARE 9800 FLUOROTRAK, IT3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA