BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM

    MDR report key: 9194840 · Received October 15, 2019

    Report

    Report Number
    1723170-2019-05234
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 13, 2019
    Report Date
    May 4, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNINTERRUPTIBLE POWER SUPPLY (UPS) FOR THE NAVIGATION SYSTEM WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT A PORT ON THE UNIT HAD NO OUTPUT VOLTAGE. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. THE PCOIP, CAMERA CART TO MAIN CART CABLE, FUSES AND COMPUTER OF THE NAVIGATION SYSTEM WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE COMPONENTS WERE FULLY FUNCTIONAL AND THE REPORTED ISSUE COULD NOT BE REPLICATED ON EACH COMPONENT. PN: 9735787, LN: 19160032. PN: 9735764, LN: 1920C01415. PN: 9735796, LN: 71AJ60S6J2. PN: 9735772, LN: 190304. 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 MULTIPLE TIMES. ON THE FIRST VISIT BY THE FIELD SERVICE ENGINEER ON (B)(6) 2019, THE CENTRAL PROCESSING UNIT (CPU) OF THE COMPUTER WAS REPLACED. THE ISSUE PERSISTED, INDICATING A POWER PROBLEM. ON THE SECOND VISIT ON (B)(6) 2019, IT WAS FOUND THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) V1 CHANNEL WAS BROKEN. ON THE THIRD VISIT, THE UPS WAS REPLACED WHICH RESOLVED THE BOOT-UP ISSUE. HOWEVER, DURING THIS THIRD VISIT ON (B)(6) 2019, A VIDEO COMMUNICATION/SIGNAL PROBLEM WAS IDENTIFIED BETWEEN THE CART MONITORS, INDICATING AN FDA REPORTABLE EVENT. ON A FOURTH VISIT ON (B)(6) 2019, THE PC OVER IP (PCOIP) ZERO AND COMMUNICATION CABLE BETWEEN CARTS WAS REPLACED WHICH RESOLVED THAT ISSUE. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9735796 (PCOIP), SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI# UNKNOWN; PRODUCT ID: 9735772 (CABLE), SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI# UNKNOWN. 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 SYSTEM BEING USED PRE-OPERATIVELY FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE COMPUTER WAS NOT BOOTING UP AND THAT A SURGERY COULD NOT BE DONE USING THE SYSTEM. THE SURGERY WAS PERFORMED WITH A DIFFERENT NAVIGATION SYSTEM. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. ON THE FIRST VISIT BY THE FIELD SERVICE ENGINEER, THE CENTRAL PROCESSING UNIT (CPU) OF THE COMPUTER WAS REPLACED. THE ISSUE PERSISTED, INDICATING A POWER PROBLEM. ON THE SECOND VISIT, IT WAS FOUND THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) V1 CHANNEL WAS BROKEN. ON THE THIRD VISIT, THE UPS WAS REPLACED WHICH RESOLVED THE BOOT-UP ISSUE. HOWEVER, DURING THIS THIRD VISIT ON (B)(6) 2019, A VIDEO COMMUNICATION/SIGNAL PROBLEM WAS IDENTIFIED BETWEEN THE CART MONITORS. ON A FOURTH VISIT, THE PC OVER IP (PCOIP) ZERO AND COMMUNICATION CABLE BETWEEN CARTS WAS REPLACED WHICH RESOLVED THAT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988325 STEALTHSTATION S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR