BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 8215439 · Received January 3, 2019

    Report

    Report Number
    3004785967-2019-00015
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    UDI-DI
    00643169353428
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT AFTER REPLACING THE MVS INTERFACE THE SYSTEM BEGAN FUNCTIONING AS INTENDED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. H4) MISSING DEVICE MANUFACTURE DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHEN BOOTING UP THE SYSTEM, THE IMAGE ACQUISITION SYSTEM (IAS) SHOWS READY STATUS FOR EVERYTHING EXCEPT THE LAST CHECKMARK. THIS SHOWS AS "NOT CONNECTED TO MOBILE VIEW STATION (MVS)." SITE HAD TRIED MULTIPLE REBOOTS WITH NO RESOLUTION. TECHNICAL SERVICES (TS) TRIED REMOTING INTO THE IAS COMPUTER TO LOOK FOR ERRORS, BUT IT STATED THAT IT COULD NOT CONNECT TO THE COMPUTER EVEN THOUGH THE IAS WAS ON. THE UMBILICAL CABLE WAS RESEATED WITHOUT RESOLUTION. THE UMBILICAL CABLE (INCLUDING INTERNAL PINS) HAD NO VISIBLE DAMAGE. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7991 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000028120 00643169353428

    Patients

    Seq Age Sex Outcome Treatment
    1