BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6094254 · Received November 10, 2016

    Report

    Report Number
    1723170-2016-03365
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    July 14, 2015
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS FOUND THAT THE COMPUTER WOULD NOT BOOT UP. IT WOULD TURN ON AND THEN THROW AN ERROR MESSAGE. AFTER PRESSING OK, IT WOULD BOOT UP NORMALLY BUT WOULD FREEZE UP CONTINUOUSLY. WEN TRYING TO REBOOT, IT WOULD NOT TURN ON AND A GREEN EXCLAMATION LIGHT WOULD JUST FLASH. REPLACING THE CENTRAL PROCESSING UNIT (CPU) FIXED THE ISSUES. THERE WAS ALSO AN ISSUE WITH THE UMBILICAL CABLE. THE IMAGING SYSTEM AND MVS WOULD NOT CONNECT ON BOOT UP (WOULD SAY CONNECTED, NOT READY). THERE WAS A BROKEN WIRE IN THE UMBILICAL CABLE. REPLACING THE UMBILICAL FIXED THE ISSUE. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF THE COMPUTER MVS SERVER FOUND THAT THE COMPUTER BOOTED UP AS EXPECTED ON THE BENCH. WHEN INSTALLED IN THE IMAGING SYSTEM, SYSTEM WOULD SAY "CONNECTED, NOT READY" ON THE PENDANT. WHEN COMPUTER WAS REPLACED WITH A KNOWN GOOD COMPUTER IT PASSED, IMAGING SYSTEM POWERED UP AND FUNCTIONED AS EXPECTED. THE HARDWARE INVESTIGATION FOUND THAT REPORTED EVENT WAS RELATED TO AN ELECTRICAL FAILURE, BAD NIC1 PORT. HARDWARE INVESTIGATION OF THE CABLE MVS INTERFACE CONFIRMED REPORTED PROBLEM "BROKEN WIRE IN CABLE". UMBILICAL CABLE FAILED BENCH LEVEL TEST. FOUND BROKEN CABLE WIRES [PINS 1 AND 4] LEMO END. NO FAULT FOUND TO REPORTED ISSUE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) 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 REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. 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 IMAGING SYSTEM'S MOBILE VIEW STATION (MVS) COMPUTER WOULD NOT BOOT UP AND THAT HE WAS SEEING A SOLID ORANGE LIGHT. HE WAS NOT ABLE TO ACCESS ANY GRAPHICAL USER INTERFACE (GUI). THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744255 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