BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6064484 · Received October 28, 2016

    Report

    Report Number
    1723170-2016-03293
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    June 12, 2015
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM WAS NOT BOOTING UP. THE MOTION AND GENERATOR BARS ON THE IMAGING SYSTEM PENDENT WERE BLANK STATUS AND THE MOBILE VIEW STATION (MVS) SAID DISCONNECTED WITH A RED 'X'. NO PATIENT WAS PRESENT. THE MEDTRONIC REPRESENTATIVE ATTEMPTED TO REBOOT THE IMAGING SYSTEM WITH THE UMBILICAL CABLE DISCONNECTED BUT THE SAME ISSUE OCCURRED. THE MEDTRONIC REPRESENTATIVE THEN ATTEMPTED TO REMOTE INTO THE IMAGING SYSTEM'S DESKTOP, AND RECEIVED THE FOLLOWING ERROR MESSAGES: THE TYPE INITIALIZER FOR 'BI.OARM.IAS.OARM.SYSTEMMANAGER' THREW EXCEPTION. AN ON SITE INSPECTION WAS PERFORMED AND THE SYSTEM'S LOGS WERE SENT TO THE MANUFACTURER FOR ANALYSIS. THE MEDTRONIC REPRESENTATIVE RE-LOADED THE IMAGE ACQUISITION SYSTEM'S (IAS) APPLICATION SOFTWARE, RE-CONFIGURED SYSTEM, AND THEN PERFORMED A SUCCESSFUL SYSTEM CHECKOUT. THERE WAS NO PATIENT PRESENT. A SOFTWARE INVESTIGATION WAS CONDUCTED TO ANALYZE THE SYSTEM LOGS WHERE IT WAS DETERMINED 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)(6) ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (B)(6). 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 THE IMAGING SYSTEM WAS NOT BOOTING UP. THE MOTION AND GENERATOR BARS ON THE IMAGING SYSTEM PENDENT WERE BLANK STATUS AND THE MOBILE VIEW STATION (MVS) SAID DISCONNECTED WITH A RED 'X'. NO PATIENT WAS PRESENT. THE MEDTRONIC REPRESENTATIVE ATTEMPTED TO REBOOT THE IMAGING SYSTEM WITH THE UMBILICAL CABLE DISCONNECTED BUT THE SAME ISSUE OCCURRED. THE MEDTRONIC REPRESENTATIVE THEN ATTEMPTED TO REMOTE INTO THE IMAGING SYSTEM'S DESKTOP, AND RECEIVED THE FOLLOWING ERROR MESSAGES: THE TYPE INITIALIZER FOR 'BI.OARM.IAS.OARM.SYSTEMMANAGER' THREW EXCEPTION. AN ON SITE INSPECTION WAS PERFORMED AND THE SYSTEM'S LOGS WERE SENT TO THE MANUFACTURER FOR ANALYSIS. THE MEDTRONIC REPRESENTATIVE RE-LOADED THE IMAGE ACQUISITION SYSTEM'S (IAS) APPLICATION SOFTWARE, RE-CONFIGURED SYSTEM, AND THEN PERFORMED A SUCCESSFUL SYSTEM CHECKOUT. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714603 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