BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5836401 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01619
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 6, 2015
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, A MEDTRONIC REPRESENTATIVE, OBSERVED THE MOTION SCROLL BAR SCROLLING, NOT COMPLETING SYSTEM BOOT UP. THE TECHNICAL SERVICE MODE WAS ACCESSED ON THE SYSTEM AND INDIVIDUALLY, MANUALLY, HOMED ALL MOTION CONTROLLERS. AFTER, REHOMING CONTROLLERS, THE REPRESENTATIVE WAS ABLE TO MOVE ALL MOTIONS AND THEN INVALIDATE HOME AND RE-HOME THE MOTION CONTROLLERS. THE REPRESENTATIVE CONCLUDED THE POSITIONER MOTION CONTROLLER HAD A POSSIBLE ENCODER ISSUE BUT AFTER REHOMING MOTIONS WAS NOT ABLE TO REPRODUCE ISSUE. THE IMAGING SYSTEM WAS RESTARTED MULTIPLE TIMES WITH NO OTHER ISSUES. THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. (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 SITE'S IMAGING SYSTEM REMAINED IN AN INITIALIZING STATE. THE PENDANT DISPLAYED AN ERROR MESSAGE STATING THAT "SHOWED INITIALIZING PLEASE WAIT" AND DISPLAYED A RED X FOR X-RAY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489784 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