BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 5841810 · Received August 2, 2016

    Report

    Report Number
    1723170-2016-01861
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    June 3, 2014
    Report Date
    August 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SYSTEM WAS STUCK ON "SYSTEM BOOTING, PLEASE WAIT." THE CONFIG FILES WERE NOT PRESENT IN THE SYSTEM BUT WERE LOCATED ON A USB INSIDE THE MOBILE VIEW STATION (MVS) CART. THE REP RELOADED THE CONFIG FILE AND TESTED SYSTEM. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) DISTRICT 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 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 DURING A SPINAL FUSION PROCEDURE THE IMAGING SYSTEM PENDANT REFLECTED "SYSTEM BOOTING PLEASE WAIT" FOR ABOUT 10 MINUTES AND WOULD NOT LET THEM PROCEED. THEY TRIED REBOOTING TWICE WITH NO CHANGE. TECHNICAL SERVICES WALKED THE REP THROUGH LOGGING INTO THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER REMOTELY FROM THE MOBILE VIEW STATION (MVS). HE WAS ABLE TO BUT WAS MET WITH AN ERROR MESSAGE THAT HE CLICKED OKAY AND COULD SEE THE DESKTOP. ATTEMPTED TO OPEN THE IMAGING SYSTEM APPLICATION BUT A "CONFIG FILE ERROR" MESSAGE APPEARED. TRIED TO NAVIGATE TO THE BACK-UP CONFIG FILE TO RESTORE BUT IT WAS NOT SAVED ON THE SYSTEM. THE SURGEON CHOSE TO DISCONTINUE USE OF THE IMAGING SYSTEM. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492089 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1