BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 4210980 · Received October 29, 2014

    Report

    Report Number
    1723170-2014-01155
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RETURN REQUESTED. REPLACEMENT COMPUTER SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT COMPUTER CONFIRMED SYSTEM WAS RUNNING SLOWER THAN EXPECTED. LOADING EXAMS REPEATEDLY RESULTED IN ERROR [SELECTED EXAM EXCEEDS AVAILABLE SYSTEM RESOURCES. PLEASE UNLOAD EXAMS BEFORE PROCEEDING]. MEM TEST FOUND NO FAULTS, AS WELL AS, SMART DATA FOR HDD HAD NO ERRORS. VERIFIED BIOS SETTINGS. SYSTEM PERFORMS SLOW. REPEATED PREVIOUS STEPS WITH DIFFERENT VGC, BROUGHT NO IMPROVEMENT. RE-IMAGE SYSTEM, INSTALL FSN 2.2.2 AND SYSTEM PERFORMANCE IMPROVES, NO RESOURCE ERRORS ENCOUNTERED. POSSIBLE SOFTWARE SETTING OR FILE CORRUPTION. SOFTWARE FAILURE - SOFTWARE FUNCTIONALITY - CAUSED EVENT.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO REPLACE THE COMPUTER AND TEST THE EQUIPMENT. THE HARDWARE AND SOFTWARE PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION. AS PREVIOUSLY REPORTED, THE MOST LIKELY CAUSE WAS A HARD DISK CORRUPTION DURING SOFTWARE INSTALLATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SITE FUSION NAVIGATION SYSTEM THAT WAS UNRESPONSIVE WHILE LOADING THE SOFTWARE, PRIOR TO THE START OF A PROCEDURE. THE SURGEON RE-BOOTED THE NAVIGATION SYSTEM AND THE SOFTWARE THEN LOADED PROPERLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. THE SUBSEQUENT PROCEDURE WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692009 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1