BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL 2.1 BRAINLAB NEURONAVIGATION SOFTWARE

    MDR report key: 3200929 · Received June 20, 2013

    Report

    Report Number
    3200929
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BRAINLAB INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ANESTHETIZED FOR CRANIOTOMY PROCEDURE FOR A BRAIN MASS. AFTER HER SCAN WAS LOADED WITHOUT DIFFICULTY, AN ERROR MESSAGE WAS NOTED INDICATING THAT THE NAVIGATION SOFTWARE WAS CORRUPTED. NUMEROUS REBOOTS WERE ATTEMPTED WITHOUT SUCCESS. THE LOCAL SALES REPRESENTATIVE WAS NOT IMMEDIATELY AVAILABLE AND TECHNICAL SUPPORT FROM THE COMPANY ADVISED THAT THE SOFTWARE REP WOULD HAVE TO COME IN TO FIX THE PROBLEM. ANOTHER PATIENT DISK WAS ATTEMPTED TO DETERMINE IF THE FAILURE WAS SPECIFIC TO THE PATIENT'S DISK. THE FAILURE WAS DETERMINED TO NOT BE RELATED TO THE DISK, BUT SOFTWARE RELATED. PROCEDURE WAS CONTINUED WITHOUT THE USE OF THE BRAINLAB NEURONAVIGATION. SALES REP CAME TO TROUBLESHOOT THE ISSUE LATER AND HAD TO RELOAD SOFTWARE. SHE FELT THAT THE MALFUNCTION MAY HAVE OCCURRED DUE TO MULTIPLE INAPPROPRIATE SHUTDOWN PROCEDURES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CRANIOTOMY USING NEURONAVIGATIONDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281064 CRANIAL 2.1 BRAINLAB NEURONAVIGATION SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT, SOFTWARE HAW BRAINLAB INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR