BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5830863 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01610
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    August 28, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE INVESTIGATING THE REPORTED ISSUE, A MEDTRONIC REPRESENTATIVE CONFIRMED THAT THE INTERFACE CABLE HAD BROKEN COMMUNICATION WIRE AT THE LEMO CONNECTOR CAUSING UNIT TO BOOT INTO " CONNECTED, BUT NOT READY " STATUS. A REPLACEMENT INTERFACE CABLE WAS SHIPPED TO THE SITE. THE MEDTRONIC REPRESENTATIVE REPLACED THE INTERFACE CABLE AND PERFORMED A MECHANICAL AND FUNCTIONAL TEST OF THE IMAGING SYSTEM. THE TEST REVEALED THAT REPLACING THE INTERFACE CABLE RESOLVED THE ISSUE. AFTER PART REPLACEMENT A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE INTERFACE CABLE WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ON-SITE INVESTIGATION WAS COMPLETED ON THE RETURNED INTERFACE CABLE. THE MEDTRONIC INVESTIGATION, CONFIRMED THE REPORTED PROBLEM "STAND ALONE MODE. FOUND BROKEN CABLE INSIDE LEMO¿. THE CABLE FAILED FUNCTIONAL TESTING AND REVEALED BROKEN CABLE WIRES. 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, WHILE IN A SPINE PROCEDURE, THE SITE'S IMAGING SYSTEM WOULD NOT INITIALIZE ON THE IMAGING SYSTEM PENDANT. THE STANDALONE MODE WAS DISPLAYED AND AN ERROR THAT READ, "ERROR: 3RD PARTY....¿ IN TROUBLE-SHOOTING, THE IMAGING SYSTEM THE MEDTRONIC REPRESENTATIVE UNPLUGGED AND RE-PLUGGED THE INTERCONNECT CABLE, WHICH SEEMED TO START THE COMMUNICATION ACCORDING TO THE PENDANT. THE MVS DISPLAYED "UNEXPECTED ERROR OCCURRED AND SOFTWARE WILL REBOOT." THE SURGEON DISCONTINUED USE OF THE BOTH THE IMAGING SYSTEM AND NAVIGATION SYSTEM AND CHOSE TO PROCEED WITH A C-ARM, AN ALTERNATE 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
    482478 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 58 YR