BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8702750 · Received June 17, 2019

    Report

    Report Number
    1723170-2019-03419
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    January 22, 2018
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: COMPUTER 9734477 ROLLINGSTONE EMBEDDED, SERIAL/LOT #: (B)(4), UDI#: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO INSPECT THE SYSTEM. THE COMPUTER WAS REPLACED AND THE ISSUE RESOLVED. THE SOFTWARE INVESTIGATION FOUND THAT IT WAS NOT POSSIBLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE BEHAVIOR CANNOT BE REPLICATED. THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. FUNCTIONAL TESTING; VISUAL/PHYSICAL EXAMINATION; PROCEDURALIZED DEVICE TESTING WERE PERFORMED AND NO FAILURE WAS FOUND. THE RETURNED PART PASSED ALL TESTS. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SWITCHED TO NO INPUT DETECTED. THE SYSTEM WAS IN THE ADMIN LOGIN SCREEN AND IT WENT TO SLEEP, BUT IT WOULD NOT COME UP AGAIN IF THE MOUSE WAS MOVED OR IF THEY TYPED. THE SITE THEN REBOOTED WITH THE POWER SWITCH AND IT CAME UP. THE SITE WAS ATTEMPTING TO REPLICATE THE ISSUE AND SHUTTING DOWN FROM THE APPLICATION LAUNCH SCREEN, INSTEAD OF GOING TO THE POWER DOWN SCREEN IT SWITCHED TO NO INPUT DETECTED AS WELL. THIS OCCURRED THREE TIMES, WITH THE SYSTEM REMAINING AT THE 'NO INPUT DETECTED' SCREEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496259 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1