BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8509043 · Received April 12, 2019

    Report

    Report Number
    1723170-2019-01705
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169504394
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THERE WAS NO FAULT FOUND WITH THE SYSTEM, AND NO COMPONENTS WERE REPLACED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. SOFTWARE ANALYSIS VIA DESIGN ANALYSIS METHODOLOGY CONCLUDED THAT THE BEHAVIOR DESCRIBED WAS THE INTENDED BEHAVIOR OF THE SOFTWARE, THERE WAS FAULT IDENTIFIED WITH THE SOFTWARE. ADDITIONALLY, IT WAS DETERMINED THAT THE SITE WASN¿T BURNING THE DISCS PROPERLY. THEY INSTALLED A NEW CD BURNER AND THE DISCS THEN LOADED PERFECTLY. 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 OUTSIDE OF A PROCEDURE THAT AS THE SITE WAS LOADING UNSTRUCTURED ALTERNATE THE SYSTEM BECAME UNRESPONSIVE AND WOULD NOT LOAD THE IMAGES. THE SITE STATED IT (DISC) WAS IN THE DRIVE FOR ABOUT 10 MINUTES. THERE WAS NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED: THE CLINICAL SPECIALIST (CS) REPORTED THAT THE DOCTOR'S OFFICE WASN¿T BURNING THE DISCS PROPERLY. THE SITE INSTALLED A NEW CD BURNER (ON THEIR OFFICE EQUIPMENT, NOT THE NAVIGATION SYSTEM) AND THE DISCS THEN LOADED PERFECTLY. THE CS PERFORMED A SYSTEM CHECKOUT AND EVERYTHING WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304011 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560 N06267329 00643169504394

    Patients

    Seq Age Sex Outcome Treatment
    1