BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRAK 35001

    MDR report key: 1220650 · Received October 31, 2008

    Report

    Report Number
    1225258-2008-00015
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 31, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP HAD THE NURSE CHECK THE POSITION OF THE TRANSMITTER TO THE HEADSET AND HEADSET TO THE PATIENT, EVERYTHING CHECKED OUT OK ACCORDING TO THE NURSE. HE INSTRUCTED THE SURGEON REDO THE REGISTRATION, CALIBRATION AND VERIFICATION, THEN CHECK ONE OF THE METAL BB'S ON THE HEADSET WITH THE TIP OF THE ASPIRATOR. THE ACCURACY WAS PERFECT, THEN HE HAD THEM CHECK THE VERIFICATION POINT AND THE PATIENTS ANATOMY AND WERE STILL OFF AS MUCH AS 3 MM STILL. WITHOUT USING ACCUMATCH THEIR ONLY OPTION FOR USING NAVIGATION WILL BE TO RE-SCAN THE PATIENT. THE GE REP'S IMPRESSIONS ARE THAT THE HEADSET WAS IMPROPERLY POSITIONED OR MOVE DURING THE CT SCAN. CASE WAS PUT ON HOLD UNTIL THEY COULD TALK WITH CT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE HAVING A PROBLEM WITH THE ACCURACY BEING OFF BETWEEN 3-5 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITRAK 35001 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1