BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6095617 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-03382
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    March 20, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE IMAGING SYSTEM FAILED IMAGING MODALITIES. SYSTEM GETTING DATABASE ISSUE. THE MEDTRONIC REPRESENTATIVE REPLACED THE MOBILE VIEW STATION (MVS) COMPUTER AND UPGRADED THE EXTERNAL VIDEO CONVERTER. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF THE MULTIVIDEO SYSTEM CONVERTER COULD NOT DUPLICATE REPORTED PROBLEM. PASSED BENCH TEST AND WAS FUNCTIONING AS NORMAL. RETURNED BECAUSE OF A MVS UPGRADE PER FIELD RETURN TAG. NO FAULT FOUND. THE HARDWARE INVESTIGATION OF THE COMPUTER MVS SERVER CONFIRMED REPORTED PROBLEM "FAILS TO BOOT UP." VISUAL INSPECTION NOTES CD DRIVE IS NOT STOCK, FRONT BEZEL IS LOOSE AND POWER SUPPLY DOES NOT SEAT PROPERLY. FUNCTIONAL TESTING CONFIRMED BOOTMGR MISSING ON START UP. BIOS HAD MANY INCORRECT SETTINGS CONFIGURE SATA AS RAID WAS SET TO DISABLED, MEMORY MAPPED I/O START WAS INCORRECT VALUE (2.5GB RATHER THAN 3.0GB), AND RESUME ON AC POWER LOSS WAS SET TO STAY OFF. TIME AND DATE (CMOS CHECK) WERE CORRECT. SET BIOS AS DIRECTED FOR REV 5 COMPUTER IN TB10-004, AS WELL AS CLEARED THE SYSTEM LOGS. SAVE AND EXIT. AFTER POWER CYCLED, BOOTMGR CONTINUED TO BE DISPLAYED ON START UP. PERFORMED RAID AND ATTEMPTED TO RELOAD SOFTWARE. SOFTWARE RELOAD WAS NOT SUCCESSFUL. WOULD NOT PROCEED BEYOND BOOTMGR FAILURE. IT WAS FOUND TO HAVE A FAULTY MVS COMPUTER. THE REPORTED EVENT WAS RELATED TO A CENTRAL PROCESSING UNIT (CPU) MALFUNCTION. 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: 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 SITE BIOMED REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM WAS DISPLAYING A CRITICAL FAILURE MESSAGE. NO OTHER DETAILS WERE PROVIDED TO HIM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746790 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