BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5830786 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01603
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    July 4, 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 Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, A MEDTRONIC REPRESENTATIVE DETERMINED THAT THE DOOR RAILING HAD SLIPPED OUT CAUSING THE SYSTEM DOOR TO NOT CLOSE. THE RAILING WAS REALIGNED AND SYSTEM REHOMED. THE REPRESENTATIVE ALSO REPLACED THE MOTION CONTROLLER AS A PRECAUTION TO THE DOOR NOT OPENING ISSUE. NO ISSUES FOUND WITH THE MOTION CONTROLLER, IT WAS FOUND TO BE FULLY FUNCTIONAL. AFTER PART REPLACEMENT, A MEDTRONIC REPRESENTATIVE, PERFORMED AN IMAGING SYSTEM CHECK-OUT, THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE MOTION CONTROL BOX WAS RETURNED TO MEDTRONIC FOR ANALYSIS. AN ON-SITE FUNCTIONAL AND PERFORMANCE INVESTIGATION WAS COMPLETED ON THE RETURNED MOTION CONTROL BOX. MEDTRONIC INVESTIGATION COULD NOT CONFIRM THE REPORTED DOOR CLOSING PROBLEM. THE RETURNED MOTION CONTROL BOX WAS INSTALLED IN AN IMAGING SYSTEM AND RAN WITHOUT ANY ISSUES. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. 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 (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 (B)(6) 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 THE SITE WAS UNABLE TO OPEN THE DOOR AND REMOVE THE IMAGING SYSTEM AFTER HAVING THE SYSTEM IN AN OBLIQUE POSITION AND TRYING TO MOVE TO AN AP ANGLE. THE IMAGING SYSTEM MADE A STRANGE SOUND AND THEY TRIED TO OPEN THE DOOR WITH NO SUCCESS. THEY ALSO TRIED THE OVERRIDE SIDE BUTTON WITH NO SUCCESS. THEY WERE ABLE TO USE THE RATCHET TO OPEN THE DOOR AND REMOVE THE SYSTEM FROM THE ROOM. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THIS CAUSED A 20 MINUTE DELAY TO THE CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482046 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 48 YR