BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 8701791 · Received June 14, 2019

    Report

    Report Number
    1723170-2019-03354
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    February 21, 2018
    Report Date
    June 14, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED/MARKETED IN THE US, BUT IS SIMILAR TO A DEVICE THAT IS APPROVED IN THE US UNDER K050438. OTHER RELEVANT DEVICE(S) ARE: SOFTWARE (B)(4) FUSION ENT APP; UPN (B)(4). THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. 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 WHEN THE EM STRAIGHT PROBE WAS VERIFIED ON THE ENT APPLICATION, THE SCREEN TURNED BLUE. VERIFICATION WAS ATTEMPTED AGAIN AFTER A SYSTEM RESTART BUT THE ISSUE RECURRED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495181 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1