BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5815733 · Received July 22, 2016

    Report

    Report Number
    1723170-2016-01503
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    April 8, 2014
    Report Date
    July 22, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION: ON (B)(6) 2014, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND PERFORMED AN IMAGING SYSTEM CHECKOUT. THE ISOLATED STANDALONE BOARD FAILED TESTING. THE FAILURE WAS RESOLVED UPON REPLACING THE STANDALONE BOARD. DURING THE SYSTEM CHECKOUT, THE MOBILE VIEW STATION (MVS) COMPUTER WAS INDICATING A FAULT ON BOOT UP AND CAUSING LOSS OF BIOS SETTINGS. ON (B)(6) 2014, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND PERFORMED AN IMAGING SYSTEM CHECKOUT. THE MVS COMPUTER FAILED TESTING. THE FAILURE WAS RESOLVED UPON REPLACING THE MVS COMPUTER AND RESTORING SETTINGS. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE STANDALONE BOARD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND AN ELECTRICAL FAILURE MODE WAS CONFIRMED. THE MVS COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND A SOFTWARE FAILURE WAS CONFIRMED. COMPUTER ENTERS INTO BIOS PASSWORD WITHOUT ANY KEY STROKE. AFTER RESETTING THE BASIC INPUT OUTPUT SETTING (BIOS), THE WINDOWS ERROR "CONFIG FILE IS MISSING/CORRUPT" APPEARS. THE FAILURE WAS DUE TO A CORRUPT OPERATING SYSTEM (OS), WHICH WOULD CAUSE THE BIOS LOGIN SCREEN TO SOMETIMES SHOW UP ON BOOT UP WHEN F2 WAS NEVER PUSHED; RANDOM LOSS OF BIOS SETTINGS; DATABASE ERRORS WHEN PERFORMING SYSTEM BACKUP. 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-(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 (B)(6) 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 THE USER WAS UNABLE TO SWITCH THE IMAGING SYSTEM FROM 2D TO 3D MODE AT THE BEGINNING OF A SPINAL FUSION PROCEDURE. THE SURGEON WAS STILL OPENING AND DID NOT NEED IMAGING AT THIS POINT. THE SYSTEM WAS REBOOTED; HOWEVER, DURING REBOOT, IT PAUSED ON "INITIALIZING, PLEASE WAIT" FOR ABOUT TEN MINUTES AND DISPLAYED SCROLLING GENERATOR BARS. THE SYSTEM WAS REBOOTED AGAIN BUT THE SAME BEHAVIOR WAS OBSERVED. ADDITIONALLY, THE MOBILE VIEW STATION (MVS) MONITOR WAS COMPLETELY BLACK. DURING ANOTHER ATTEMPT TO REBOOT, BOTH LINE POWER AND SYSTEM ON LIGHTS WERE ILLUMINATED, BUT THE SCREEN NEVER CAME UP, AND NO LIGHTS WERE ON IN THE GRATES OF THE MONITOR. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE; HOWEVER, THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470273 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 60 YR