BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1961564 · Received December 27, 2010

    Report

    Report Number
    1723170-2010-00222
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN. TECHNICAL SERVICES PROVIDED INSTRUCTIONS AT THE TIME OF THE EVENT TO REMOVE UNUSED CT EXAMS AND SET UP A DIRECTORY FOR THE CORE FILES ON THE SYSTEM. THE MOUSE AND KEYBOARD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE DEVICES WERE FULLY FUNCTIONAL WHEN CONNECTED TO KNOWN GOOD SYSTEM. A MEDTRONIC REPRESENTATIVE TESTED THE SYSTEM WITH THE REPLACED PARTS AND REPORTED THAT THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SOFTWARE WAS FREEZING BEFORE STARTING AN ENT CASE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE