BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 8861489 · Received August 5, 2019

    Report

    Report Number
    1723170-2019-04372
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 10, 2019
    Report Date
    September 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND BATTERY WERE REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. EVALUATION CODES 10, 114, AND 4307 ARE ASSOCIATED WITH THE SYSTEM CHECKOUT. EVALUATION CODES 114, 3221, AND 4315 ARE ASSOCIATED WITH THE REPLACED COMPONENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735787, SERIAL/LOT #: (B)(4), UBD: UNKNOWN, UDI#: UNKNOWN. THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE UPS HAD BLOWN FETS. OTHERWISE; ALL OUTPUTS MEASURED EXPECTED VOLTAGE AND THE POWER BUTTON FUNCTIONS, AS INTENDED. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SITE DID NOT REMEMBER IF THE SYSTEM WAS PLUGGED IN OR UNPLUGGED AT THE TIME OF THE POWER DOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SYSTEM POWERED DOWN. THE SITE WAS ABLE TO SEE THE RED FLASHING BATTERY LIGHT BEFORE THIS HAPPENED. THE SITE WAS ABLE TO POWER ON TO PROCEED. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE. AN UPDATE WAS LATER PROVIDED THAT THE MAIN CART UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERY WAS AT 0%. WHEN THE SYSTEM WAS UNPLUGGED FROM THE WALL, IT POWERED DOWN RIGHT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655145 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR