BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8516969 · Received April 16, 2019

    Report

    Report Number
    1723170-2019-01765
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    January 30, 2018
    Report Date
    April 15, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF CASE PART (B)(4) DETERMINED THAT THE SOFTWARE WAS UNRESPONSIVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN OPENING STANDALONE DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) QUERY/RETRIEVE (QR) A MANUFACTURER REPRESENTATIVE RECEIVED A SR MANAGER FAILURE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312465 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM

    Patients

    Seq Age Sex Outcome Treatment
    1