BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6063431 · Received October 28, 2016

    Report

    Report Number
    1723170-2016-03213
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    February 16, 2016
    Report Date
    October 28, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE REPORTED SOME ISSUES SETTING UP THE IP ADDRESS AND VERIFYING CONNECTION WITH THE NAVIGATION SYSTEM. THIS WAS OUTSIDE OF SURGERY. THE REP WAS ABLE TO VERIFY/PING THE NAVIGATION SYSTEM FROM THE MOBILE VIEW STATION (MVS) APPLICATION. THE NAVIGATION SYSTEM THEN INDICATED AN ORANGE STATUS LINE AND ABILITY TO SEND AN EXAM FROM THE IMAGING SYSTEM WAS INTERMITTENT (VARIES AS UMBILICAL CABLE IS MANIPULATED AND RE-SEATED). REP TRIED TO LOGIN INTO THE IMAGE ACQUISITION SYSTEM (IAS) DESKTOP, ON THE FIRST ATTEMPT THE SYSTEM DISPLAYED THE FOLLOWING ERROR MESSAGE WHEN IAS IS SELECTED: "THIS COMPUTER HAS BEEN LOCKED". CONNECTION WAS SUCCESSFULLY ESTABLISHED ON THE SECOND ATTEMPT. THE IMAGING SYSTEM APPLICATION INDICATED "ACTIVE" FOR NAVIGATION STATUS BUT NAVIGATION STATE SAID "LOST CONNECTION". TO FURTHER TROUBLESHOOT. THE REP BYPASSED BOTH THE IMAGING SYSTEM AND NAVIGATION SYSTEM BULKHEAD AND ISSUE PERSISTED. UPON ONSITE INVESTIGATION, THE MOBILE VIEW STATION (MVS) UMBILICAL CABLE WAS REPLACED AND SENT BACK TO MEDTRONIC FOR ANALYSIS. FOLLOWING RETURNED CABLE ANALYSIS, THE ISSUE COULD NOT BE REPLICATED AS THE CABLE PASSED ALL TESTS AND PERFORMED AS INTENDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. A FULL SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. 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 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 SOME ISSUES SETTING UP THE IP ADDRESS AND VERIFYING CONNECTION WITH THE NAVIGATION SYSTEM. THIS WAS OUTSIDE OF SURGERY. THE REP WAS ABLE TO VERIFY/PING THE NAVIGATION SYSTEM FROM THE MOBILE VIEW STATION (MVS) APPLICATION. THE NAVIGATION SYSTEM THEN INDICATED AN ORANGE STATUS LINE AND ABILITY TO SEND AN EXAM FROM THE IMAGING SYSTEM WAS INTERMITTENT (VARIES AS UMBILICAL CABLE IS MANIPULATED AND RE-SEATED). REP TRIED TO LOGIN INTO THE IMAGE ACQUISITION SYSTEM (IAS) DESKTOP, ON THE FIRST ATTEMPT THE SYSTEM DISPLAYED THE FOLLOWING ERROR MESSAGE WHEN IAS IS SELECTED: "THIS COMPUTER HAS BEEN LOCKED". CONNECTION WAS SUCCESSFULLY ESTABLISHED ON THE SECOND ATTEMPT. THE IMAGING SYSTEM APPLICATION INDICATED "ACTIVE" FOR NAVIGATION STATUS BUT NAVIGATION STATE SAID "LOST CONNECTION". TO FURTHER TROUBLESHOOT, THE REP BYPASSED BOTH THE IMAGING SYSTEM AND NAVIGATION SYSTEM BULKHEAD AND ISSUE PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716398 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