BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6063704 · Received October 28, 2016

    Report

    Report Number
    1723170-2016-03214
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    February 21, 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
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOLOGIC TECHNICIAN CALLED TO REPORT THAT THEIR IMAGING DEVICE IS STUCK AND SHOWING THE MESSAGE 'SYSTEM BOOTING, PLEASE WAIT.' THIS WAS PRIOR TO A CASE, NO PATIENT PRESENT. OVER-THE-PHONE TROUBLESHOOTING WAS PERFORMED BY DOING THE FOLLOWING: REBOOTED THE SYSTEM WITH THE MOBILE VIEW STATION (MVS) UMBILICAL CORD DISCONNECTED, ISSUE PERSISTED. WALK THE REPORTER THROUGH TRYING TO ACCESS THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER VIA REMOTE DESKTOP, RECEIVED AN "UNABLE TO CONNECT" ERROR MESSAGE. UPON ON-SITE INVESTIGATION BY THE FIELD REP, IT WAS DISCOVERED THAT THE WINDOWS SYSTEM32 REGISTRY FILES WERE CORRUPTED, REP WAS UNABLE TO LOAD INPUT/OUTPUT FILES ON THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER, REP REQUESTED A REPLACEMENT COMPUTER AND RETURNED THE AFFECTED ONE BACK TO MEDTRONIC. FOLLOWING RETURNED COMPUTER ANALYSIS, THE ISSUE COULD NOT BE REPLICATED, HOWEVER, ANALYSIS FOUND THE 12 VOLT POWER CABLE CONNECTOR WAS MISSING AND INTERNAL WIRES TO CONNECTOR WERE DAMAGED. IMAGE ACQUISITION SYSTEM (IAS) COMPUTER WAS REPLACED AND ISSUE WAS RESOLVED. NO OTHER ISSUES WERE REPORTED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. 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

    RADIOLOGIST CALLED TO REPORT THAT THEIR IMAGING DEVICE IS STUCK AND SHOWING THE MESSAGE 'SYSTEM BOOTING, PLEASE WAIT.' THIS WAS PRIOR TO A CASE, NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716233 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