BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8724713 · Received June 21, 2019

    Report

    Report Number
    1723170-2019-03750
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169518452
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CART 9733560XOM FUSION EM SYSTEM SERIAL # (B)(4) FOUND NO FAILURE, AS IT PASSED THE WORK ORDER. ANALYSIS OF THE COMPUTER 9735416R ZEPPELIN FUSION RFRB (LOT #: 1895281) FOUND A MOTHERBOARD MALFUNCTION, AS THE COMPUTER WOULD BOOT JUST PAST THE LOGO AND THEN RESTART. THE COMPUTER FAILED THE PHD VESA RAM MEMORY TEST (VIDEO CARD MEMORY TEST). ANALYSIS OF THE HD DRIVE 9734699 CD/DVD-RW SATA BEIGE (LOT #: 1013839L112) FOUND THAT WHEN CONNECTED TO A KNOWN GOOD COMPUTER, THE DRIVER HAD NO POWER. ANALYSIS OF THE COMPUTER ZEPPELIN EMBEDDED (LOT #: 1935150) FOUND NO FAILURE, AS THE REPORTED ISSUES WERE NOT OBSERVED. ANALYSIS OF THE SYSTEM (B)(4) EM REWORK (LOT #: N06083829) FOUND NO FAILURE, AS THE ISSUE COULD NOT BE CONFIRMED. THE RETURNED SYSTEM WAS POWERED ON AND THE LOGIN SCREEN CAME UP, AS NORMAL. MULTIPLE RESTARTS WERE SUCCESSFUL. THE SYSTEM WAS MONITORED FOR TWO HOURS AND IT DID NOT POWER CYCLE, AS REPORTED. ENT APPLICATION LAUNCHED AND FUNCTIONED AS EXPECTED. PRODUCT EVENT SUMMARY #FUSION SYSTEM NOT BOOTING UP. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733560R, SERIAL/LOT #: (B)(4); PRODUCT ID: 9735368, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9734699, SERIAL/LOT #: (B)(4); PRODUCT ID: 9735416R, SERIAL/LOT #: (B)(4). 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 WAS CYCLING POWER. IT WOULD BOOT UP JUST PAST THE MEDTRONIC LOGO AND THEN RESTART. SITE CONFIRMED THAT POWER AND VIDEO CABLES WERE PROPERLY SEATED. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516853 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM 00643169518452

    Patients

    Seq Age Sex Outcome Treatment
    1