BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6062453 · Received October 27, 2016

    Report

    Report Number
    1723170-2016-03286
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    August 26, 2015
    Report Date
    October 27, 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

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN THE MOBILE VIEW STATION (MVS) WAS BOOTED UP A WINDOW POPPED UP PROMPTING THEM TO ENTER A PASSWORD. THIS APPEARED AFTER THE INTEL SCREEN. THE SITE WAS NOT HITTING ANY BUTTONS ON THE KEYBOARD DURING THE BOOT PROCESS. THE SITE REBOOTED A FEW TIMES AND RECEIVED THE SAME PROMPT EACH TIME. THE MEDTRONIC REPRESENTATIVE TRIED TO ENTER "BIUSER" AND "BIADMIN" BUT IT NOT RESOLVE THE ISSUE. THE SITE REPRESENTATIVE THEN HIT "CTRL+ALT+BACKSPACE" ON THE KEYBOARD AND THE MVS STARTED UP AS EXPECTED. THERE WAS A PATIENT PRESENT, THE DELAY IN THE SURGERY WAS LESS THAN AN HOUR WITH NO IMPACT ON PATIENT. NO PROCESS WAS ABORTED AND THE PROCEDURE PROCEEDED AS PLANNED. A SYSTEM CHECKOUT WAS SCHEDULED FOR THE NEXT DAY. UPON PERFORMING THE SYSTEM CHECKOUT THE FAILURE WAS CONFIRMED WHEN THE MVS COMPUTER ASKED FOR A BIOS PASSWORD AT STARTUP. THE MEDTRONIC REPRESENTATIVE WAS UNABLE TO ACCESS THE BIOS. THE MVS COMPUTER WAS REPLACED AND A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. THE NON-FUNCTIONAL MVS COMPUTER WAS SENT BACK TO THE MANUFACTURER FOR ANALYSIS. FURTHERMORE, A SOFTWARE INVESTIGATION WAS INITIATED. THE MVS COMPUTER'S FAILURE WAS CONFIRMED DURING THE ANALYSIS, AND THE ROOT CAUSE WAS FOUND TO BE DUE TO THE CMOS BATTERY BEING LOW WHICH RESULTED IN THE SETTINGS BEING LOST. THE SOFTWARE INVESTIGATION CONFIRMED THAT THIS WAS NOT A SOFTWARE FAILURE BUT A COMPUTER FAILURE. 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 THAT WHEN THE MOBILE VIEW STATION (MVS) WAS BOOTED UP A WINDOW POPPED UP PROMPTING THEM TO ENTER A PASSWORD. THIS APPEARED AFTER THE INTEL SCREEN. THE SITE WAS NOT HITTING ANY BUTTONS ON THE KEYBOARD DURING THE BOOT PROCESS. THE SITE REBOOTED A FEW TIMES AND RECEIVED THE SAME PROMPT EACH TIME. THE MEDTRONIC REPRESENTATIVE TRIED TO ENTER "BIUSER" AND "BIADMIN" BUT IT NOT RESOLVE THE ISSUE. THE SITE REPRESENTATIVE THEN HIT "CTRL+ALT+BACKSPACE" ON THE KEYBOARD AND THE MVS STARTED UP AS EXPECTED. THERE WAS A PATIENT PRESENT, THE DELAY IN THE SURGERY WAS LESS THAN AN HOUR WITH NO IMPACT ON PATIENT. NO PROCESS WAS ABORTED AND THE PROCEDURE PROCEEDED AS PLANNED. A SYSTEM CHECKOUT WAS SCHEDULED FOR THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710859 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 51 YR