BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5830871 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01607
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    August 21, 2014
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. INITIAL REPORTER PHONE: (B)(6). WHILE INVESTIGATING THE REPORTED ISSUE, A MEDTRONIC REPRESENTATIVE CONFIRMED THAT THE IMAGING SYSTEM WILL NOT BOOT. THE MEDTRONIC REPRESENTATIVE REPLACED THE GANTRY MOTION CONTROL BOX AND PERFORMED A MECHANICAL AND FUNCTIONAL TEST OF THE IMAGING SYSTEM. THE TEST REVEALED THAT REPLACING THE GANTRY MOTION CONTROL BOX RESOLVED THE ISSUE. AFTER PART REPLACEMENT A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE DEVICE WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ON-SITE FUNCTIONAL AND PERFORMANCE INVESTIGATION WAS COMPLETED ON THE RETURNED GANTRY MOTION CONTROL BOX. THE MEDTRONIC INVESTIGATION CONFIRMED THE REPORTED PROBLEM "O-ARM IS NOT BOOTING, SCROLLING GREEN BAR FOR MOTION ON THE PENDANT". THIS PROBLEM WAS DETERMINED TO BE INTERMITTENT. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (B)(4). 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 SITE REPRESENTATIVE, REPORTED THAT WHILE IN A, SPINE PROCEDURE THE CUSTOMER DESCRIBED THAT THE IMAGING SYSTEM WAS NOT BOOTING. THE GREEN BARS ON THE PENDANT CAN BE SEEN BUT TWO OF THEM ARE NOT COMPLETE, THE MOTION BAR AND THE X-RAY BAR. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM AND CHOSE TO PROCEED WITH A C-ARM, AN ALTERNATE SYSTEM. THERE WAS A REPORTED NO DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482496 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 75 YR