BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8728900 · Received June 24, 2019

    Report

    Report Number
    1723170-2019-03791
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    May 30, 2019
    Report Date
    September 9, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MODEL NUMBER: 9735416R. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9733467, VERSION: 2.3. A SOFTWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH KNOWN ANOMALY DETERMINATION. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE LOT NUMBER OF THE COMPUTER (MODEL NUMBER: 9735416R) IS 1951569. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DURING INITIAL TROUBLESHOOTING THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED. FURTHER EVALUATION AT THE SITE, IDENTIFIED THAT THE MOST LIKELY CAUSE WAS THE SYSTEM COMPUTER. THE COMPUTER WAS REPLACED AND THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. 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. IT WAS REPORTED THE SYSTEM WENT TO A BLACK SCREEN WHEN BEING SET UP AND SHOWED NO INPUT DETECTED. A RESTART WORKED UNTIL THE APPLICATION LOADED AND THEN WENT TO NO INPUT AGAIN. UPON ANOTHER RESTART, THE SITE PRESSED ENTER MULTIPLE TIMES WHILE BOOTING AND THE SYSTEM WAS WORKING AFTER THAT AND WAS RUNNING BY THE TIME THE PATIENT WAS BROUGHT INTO THE ROOM. THIS ISSUE OCCURRED PREOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521044 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR