BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 9204017 · Received October 17, 2019

    Report

    Report Number
    1723170-2019-05260
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 7, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE NAVIGATION SYSTEM FUNCTIONED AS DESIGNED. HARDWARE PARTS WERE REPLACED AND THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9734477, SERIAL/LOT #: (B)(4). THE COMPUTER 9734477 ROLLINGSTONE EMBEDDED (LOT# 1802636) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND NO FAILURE. THE RETURNED COMPUTER BOOTED NORMALLY TO THE APPLICATION SCREEN. NO "NO INPUT" MESSAGES WERE OBSERVED. 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 A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING "NO INPUT DETECTED." REBOOTED THE SYSTEM AND OPEN CLINICAL APPLICATION THEN THE SCREEN WENT BLACK/BLUE. CONFIRMED ALL CABLES WERE SEATED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998371 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM

    Patients

    Seq Age Sex Outcome Treatment
    1