BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3102841 · Received May 9, 2013

    Report

    Report Number
    1723170-2013-00324
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A REPLACEMENT MONITOR VIDEO CABLE RESOLVED THE REPORTED ISSUE. THE HOSPITAL WOULD NOT ALLOW DAMAGED COMPONENTS TO LEAVE THE FACILITY.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. HE TESTED THE MONITOR BY CONNECTING EXTERNAL MONITOR VIA VGA OUTPUT ON A SIDE PANEL. THE EXTERNAL MONITOR WORKED PROPERLY WHILE THE NAVIGATION SYSTEM MONITOR SHOWS A SLIGHT SIGNAL DISRUPTION. HE WAS ABLE TO REPRODUCE THE REPORTED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM MONITOR SIGNAL BECAME BLACK WHILE THE APPLICATION SCREEN WAS ON. AFTER A FEW SECONDS THE MONITOR RESUMED IN THE WORKING MODE, APPLICATION WAS UNCHANGED, AND THERE WAS NO EFFECT ON THE SOFTWARE WORK FLOW. THERE WAS NO PATIENT PRESENT WHEN THIS CONCERN WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203311 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1