BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 3830130 · Received May 23, 2014

    Report

    Report Number
    1723170-2014-00601
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT PRESENT.A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. AFTER SPEAKING WITH TECH SUPPORT AND CHECKING THE PERCENTS AND SPACE AVAILABLE ON THE SYSTEM, THEY AGREED THAT THE COMPUTER MAY BE STARTING TO MALFUNCTION. THE REP NOTIFIED THE HOSPITAL'S ADMINISTRATION TO MAKE THEM AWARE THAT MNAV NO LONGER SUPPORTS PART REPLACEMENT FOR THESE SYSTEMS AS THEY HAVE BECOME OBSOLETE. THE SITE SAID THAT THEY ARE IN DISCUSSION ABOUT UPGRADING TO A NEWER NAVIGATION SYSTEM.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A PLANNED MAINTENANCE THE COMPUTER DID NOT BOOT UP CORRECTLY WHEN I FIRST TURNED IT ON. THE MONITOR STAYED BLANK. AFTER RESTARTING THE SYSTEM, THE COMPUTER THEN BECAME UNRESPONSIVE IN THE SETUP SCREEN AND ALSO IN THE NAVIGATE SCREEN ON THE 3RD ATTEMPT TO DO A FULL SYSTEM CHECKOUT. I WAS ABLE TO DO 3 SUCCESSFUL REGISTRATIONS WITHOUT ANY COMPUTER ISSUES OUT OF 5 OR 6 ATTEMPTS. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308562 LANDMARX EVOLUTION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. EVOLUTION

    Patients

    Seq Age Sex Outcome Treatment
    1