BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION ENT NAVIGATION SYSTEM

    MDR report key: 10484098 · Received September 2, 2020

    Report

    Report Number
    1723170-2020-02354
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 2, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169504394
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9734477R, SERIAL/LOT #: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECKOUT. THE ISSUE WAS CONFIRMED. THE COMPUTER WAS REPAIRED AND THE SYSTEM PASSED CHECKOUT. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM COULD NOT BOOT UP. WHEN THE MACHINE WAS IN NAVIGATION INTERFACE, IT WILL CRASH WHEN CONNECTED THE AXIEM TOOLS. NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946097 FUSION ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560 00643169504394

    Patients

    Seq Age Sex Outcome Treatment
    1