BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5849678 · Received August 5, 2016

    Report

    Report Number
    1723170-2016-01645
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    December 23, 2015
    Report Date
    August 5, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PART SHIPMENT WAS PLACED FOR AN IMAGING SYSTEM COMPUTER SERVICE KIT. MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, THE MEDTRONIC REPRESENTATIVE, CONFIRMED THAT THE IMAGING SYSTEM WOULD NOT BOOT. THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER WAS REPLACED. AFTER PART REPLACEMENT, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. COMPUTER SERVICE KIT - CONFIRMED REPORTED PROBLEM "DISCONNECTED AND RED X ON PENDANT." A SIMULATED USE TEST WAS PERFORMED. TWO ERRORS WERE OBSERVED: BI.OARM.SYSTEMMANAGER ERROR AND BI.OARM.IAS.DATABASE ERROR. AFTER RELOADING THE SOFTWARE ON THE IAS COMPUTER THE SYSTEM FUNCTIONS AS INTENDED. CORRUPTED OPERATING SYSTEM SOFTWARE. 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. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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 IMAGE ACQUISITION SYSTEM (IAS) IS DISCONNECTED FROM THE MOBILE VIEW STATION (MVS). WHEN BOOTING UP THE IMAGE ACQUISITION SYSTEM (IAS) AND MOBILE VIEW STATION (MVS) THE MVS CONNECTION WOULD DISPLAY "DISCONNECTED" ON THE PENDANT AND DISPLAY A RED X. ATTEMPTS WERE MADE TO REBOOT BOTH SYSTEMS WITH THE UMBILICAL CABLE DISCONNECTED AND RECONNECTED. THIS DID NOT RESOLVE THE ISSUE. REMOTE DESKTOP WAS ACCESSED BUT AN ERROR MESSAGE APPEARED WHEN ATTEMPTING TO OPEN THE IMAGING SYSTEM APPLICATION. THE SURGEON DISCONTINUED USE OF THE IMAGING AND NAVIGATION SYSTEMS AND CHOSE TO COMPLETE THE PROCEDURE WITH A C-ARM, AN ALTERNATE SYSTEM. THE SURGERY WAS SUCCESSFULLY, COMPLETED. THERE WAS NO REPORTED 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
    501479 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 42 YR