BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION NAVIGATION SYSTEM

    MDR report key: 8052079 · Received November 8, 2018

    Report

    Report Number
    1723170-2018-05572
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM FUNCTIONED AS INTENDED AFTER REPLACING THE POE INJECTOR. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE POE INJECTOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT WHEN POWERED ON AND PROVIDING POWER TO A CAMERA, THE REPLACED POE INJECTOR LED WOULD TURN GREEN AND WITHIN A FEW HOURS WOULD TURN RED. IF POE WAS UNPLUGGED FROM WALL POWER AND COOLED, POE WOULD PROVIDE POWER ONCE WALL POWER WAS RE-APPLIED. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THERE WERE NOT LIGHTS ON THE CAMERA, BUT THE CAMERA MONITOR WAS ON. THE UPS LIGHTS WERE ON. THE POE INJECTOR HAD A RED LIGHT. THE SITE BYPASSED THE TOP CAMERA CABLE AND STILL HAD NO RESPONSE. SITE THEN BYPASSED THE ENTIRE CAMERA CABLE CHAIN AND CONNECTED A NEW ETHERNET CABLE FROM THE CAMERA TO THE POE INJECTOR WITH NO CHANGE. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892514 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1