BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5820178 · Received July 25, 2016

    Report

    Report Number
    1723170-2016-01961
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 25, 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

    A MEDTRONIC REPRESENTATIVE INSPECTED THE IMAGING SYSTEM ON-SITE. IT WAS FOUND THAT THE UMBILICAL CABLE REQUIRED REPLACEMENT. THE PART WAS REPLACED AND THE ISSUE WAS RESOLVED. THE UMBILICAL CABLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS CONFIRMED THE REPORTED FAILURE PER THE RETURN TAG "DEFECTIVE." FAILED BENCH LEVEL TESTING. CAT 6 CABLE TESTING, GBIT AND 100T TESTS. THE 100T TEST PASSED. THE GBIT TEST FAILED, SHOWED OPENS BETWEEN LINES 7 AND 8. CONTINUITY TESTING FAILED. OPEN FROM LEMO CONNECTOR PIN 4 TO THREE POSITION MTE CONNECTOR PIN 2. OPEN FROM LEMO CONNECTOR PIN 5 TO THREE POSITION MTE CONNECTOR PIN 3. BOTH GBIT AN 100T TESTING WERE PERFORMED USING A CABLE VALIDATOR-NT900. PASSED VISUAL INSPECTION. A SOFTWARE INVESTIGATION WAS ALSO COMPLETED. THIS INVESTIGATION FOUND THAT THE IMAGING SYSTEM SOFTWARE WAS FUNCTIONING AS DESIGNED AND ATTRIBUTED THE REPORTED PROBLEM TO THE UMBILICAL CABLE. A COMMUNICATION FAILURE MODE WAS CONFIRMED, WITH THE ROOT CAUSE BEING A DAMAGED UMBILICAL CABLE. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED FOLLOWING PART REPLACEMENT AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE IMAGING SYSTEM DISPLAYED AN ERROR MESSAGE ON THE MOBILE VIEW STATION (MVS). THE ERROR MESSAGE STATED THAT AN ISSUE HAD OCCURRED THAT MAY AFFECT NAVIGATION AND ACCURACY. THE SURGEON WAS ABLE TO USE THE ANTEROPOSTERIOR (AP) AND LATERAL IMAGES ACQUIRED WITH THE IMAGING SYSTEM TO SUCCESSFULLY COMPLETE THE PROCEDURE. DO DELAY WAS REPORTED AND THE PATIENT WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472161 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 62 YR