BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 6178295 · Received December 15, 2016

    Report

    Report Number
    1723170-2016-05826
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 15, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. A MEDTRONIC REPRESENTATIVE INSPECTED THE NAVIGATION SYSTEM ON-SITE. DURING INSPECTION, THE REPRESENTATIVE WAS UNABLE TO RECREATE THE ISSUE. HE CHECKED ALL CONNECTIONS AND RESTORED FACTORY DEFAULTS ON THE MONITOR. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS WERE REPLACED. A FULL NAVIGATION SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM MONITOR WAS FLICKERING INTERMITTENTLY BETWEEN A COMPLETELY BLACK SCREEN AND DISPLAYING THE IMAGE. FOLLOWING THE INITIAL OCCURRENCE, THE REPORTED MALFUNCTION COULD NOT BE REPLICATED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830594 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1