BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5848086 · Received August 4, 2016

    Report

    Report Number
    1723170-2016-01770
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    December 2, 2015
    Report Date
    August 4, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 A MEDTRONIC FIELD SERVICE ENGINEER REPLACED THE MVS (MOBILE VIEWING STATION) COMPUTER. THIS RESOLVED THE ISSUE. SYSTEM PASSED ALL FUNCTIONAL TESTING AFTER COMPUTER REPLACEMENT. ANALYSIS OF SUSPECT COMPUTER AS FOLLOWS: CONFIRMED REPORTED PROBLEM "3D SPINS FAILING." MVS COMPUTER FAILED BENCH TESTING DUE TO DATABASE ERROR DISPLAYING "AN ERROR HAS OCCURRED THAT MAY HAVE DAMAGED THE SYSTEMS DATA BASE." VIRUS SCAN WAS PERFORMED AND SUCCESSFUL. INSTALLED MVS COMPUTER IN TEST O-ARM SYSTEM AND PERFORMED RAID, FOLLOWED BY SOFTWARE INSTALL (3.1.6) AND COMPUTER IS NOW FUNCTIONING AS EXPECTED. BOTH 2D AND 3D IMAGING IS SUCCESSFUL. CORRUPTED O-ARM APPLICATION CAUSING DATABASE ERROR. SOFTWARE FUNCTIONALITY PROBLEM. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE USE OF THE O-ARM IMAGING SYSTEM WAS ABORTED. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINE TRAUMA CASE THE O-ARM SYSTEM DISPLAYED A "FRAME RATE ERROR" AND "3D DISABLED ERROR" MESSAGE WHILE ATTEMPTING TO ACQUIRE A CONFIRMATION 3D SCAN. THE ERROR OCCURRED AFTER THE NAVIGATED PORTION OF SURGERY WAS COMPLETE. THEY USED C-ARMS INSTEAD FOR THE PLACEMENT VERIFICATION. NO HARM TO THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498494 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR