BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5546301 · Received April 4, 2016

    Report

    Report Number
    1723170-2016-00482
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 8, 2016
    Report Date
    April 4, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    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

    REPLACED SCU AND COMPUTER. AFTER REPLACING COMPUTER AND SCU, STILL NO COMMUNICATION WITH CAMERA. ONLY AFTER FULLY INSPECTING CAMERA CABLE, FOUND MASSIVE TEAR IN CABLE. AFTER REPLACING CAMERA CABLE THIS RESOLVED THE ISSUE. SYSTEM TESTED FULLY FUNCTIONAL AFTER ALL 3 PART REPLACEMENTS. ANALYSIS OF SUSPECT PARTS AS FOLLOWS: SCU: THE RETURNED SCU POWERED UP AND FUNCTIONED AS EXPECTED WHEN CONNECTED TO A KNOWN GOOD SYSTEM. A CHECK OF THE EVENT LOG REVEALED SEVERAL INTERMITTENT EVENTS OF NOT BEING ABLE TO COMMUNICATE WITH THE CONNECTED PSU. THIS USUALLY INDICATES A FAILURE OUTSIDE OF THE SCU. IN THIS CASE, THE RETURNED CABLE WAS FOUND TO HAVE THE FAULT. COMPUTER: NOT ABLE TO DUPLICATE THE SCU AND PSU DISCONNECTING. THE COMPUTER IS SHUTTING OFF BY ITSELF DURING BOOT UP. THE UNIT DID NOT POWER CYCLE WHILE APPLICATIONS WERE LOADED. ONE CASE COVER SCREW STRIPPED. VIDEO OUTPUT WAS WITNESSED TO BE INTERMITTENT, THIS IS THE SECOND INSTANCE OF THIS COMPUTER POWER CYCLING. ENTIRE UNIT TO BE SCRAPPED. ELECTRICAL ISSUE CAUSED EVENT. THIS ISSUE WILL BE TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE. SCU/PSU CABLE: THE RETURNED CABLE HAS BEEN PINCHED, NEARLY SEVERING THE CABLE IN HALF. A CONTINUITY CHECK CONFIRMED SEVERAL OPENS AND SHORTS. PHYSICAL DAMAGE TO CABLE CAUSED EVENT. THIS ISSUE WILL BE TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THERE WAS AN ERROR IN THE SOFTWARE AND THE INSTRUMENT STATUS SAID DISCONNECTED. THERE WERE NO LIGHTS ON THE CAMERA. THIS WAS REPORTED OUTSIDE OF A CASE. BOTH THE SCU (SYSTEM CONTROL UNITE) AND PSU (POSITION SENSOR UNIT) SHOWED DISCONNECTED IN THE SOFTWARE UTILITY APPLICATION. THE REP OPENED THE SYSTEM OUTER COVERS AND SAW THAT THE SCU HAD TWO GREEN AND ONE ORANGE LIGHT ON THE FRONT. ON THE BACK THE LIGHT WAS BLINKING ORANGE. THE SCU WAS CYCLING PERIODICALLY AND NOT COMMUNICATING WITH THE CAMERA. SOFTWARE ALSO BECOMING "HUNG UP" ON "PLEASE WAIT, LOADING SOFTWARE" BLACK SCREEN." RE-SEATED ALL CONNECTIONS - NO RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199464 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1