BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 4170079 · Received October 14, 2014

    Report

    Report Number
    1723170-2014-01082
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THE LOG FILES INDICATED A POSSIBILITY THAT THE PATIENT DATABASE WAS AT LEAST PARTIALLY CORRUPT. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. SOFTWARE INVESTIGATION NOT COMPLETED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE NAVIGATION SYSTEM BECAME UNRESPONSIVE. THE FIRST FORCED RE-START BROUGHT THE SYSTEM INTO THE BIOS BOOT-UP SCREEN, WHERE IT, AGAIN, BECAME UNRESPONSIVE. AFTER RE-STARTING, THE SYSTEM RESPONDED NORMALLY AND WAS FULLY FUNCTIONAL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED AS THE PROBLEM WAS EXPERIENCED WHEN THE HOSPITAL STAFF ATTEMPTED TO LOAD PATIENT DATA INTO THE NAVIGATION SYSTEM A FEW DAYS PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648794 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1