BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2980801 · Received February 27, 2013

    Report

    Report Number
    1723170-2013-00131
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AT THE SITE, UNINSTALLED ENT SOFTWARE APPLICATION (INCLUDING UNUSED SHARED RESOURCES) AND THEN REINSTALLED. APPLICATION IS FULLY FUNCTIONAL. ISSUE RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED A FUSION NAVIGATION SYSTEM THAT WOULD NOT LAUNCH THE ENT APPLICATION AT START-UP OR WHEN RE-BOOTED. THIS WAS IDENTIFIED OUTSIDE THE OPERATING ROOM. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85440 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1