BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6086067 · Received November 8, 2016

    Report

    Report Number
    1723170-2016-03360
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    November 3, 2015
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. FOUND THAT MOTION RELAY WAS NOT GETTING VOLTAGE TO TURN ON. REPLACED SYSTEM BOARD AND POWER SWITCHING BOARD. AFTER CORRECT VOLTAGE WAS APPLIED TO MOTION CONTROLLERS, FOUND THAT THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER WAS NOT COMMUNICATING WITH CONTROLLERS, OR COULD NOT ACCESS VIVA. REPLACED IAS COMPUTER AND SYSTEM PERFORMED AS EXPECTED. 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. THE PCBA POWER SWITCHING BOARD ASSY WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. UNABLE TO CONFIRM REPORTED PROBLEM "14 VDC NOT PRESENT AT MOTION SSR." INSTALLED POWER SWITCHING BOARD INTO IMAGING SYSTEM AND IT FUNCTIONED AS EXPECTED. THE 2D AND 3D IMAGING WERE SUCCESSFUL, AS WAS ALL MOTION. THE SYSTEM CONTROL BOARD HARDWARE INVESTIGATION UNABLE TO CONFIRM REPORTED COMPLAINT. INSTALLED SYSTEM CONTROL BOARD IN IMAGING SYSTEM AND SYSTEM FUNCTIONED AS EXPECTED. THE 2D AND 3D IMAGING WERE SUCCESSFUL, AS WAS ALL MOTION. NO PROBLEM FOUND. THE HARDWARE INVESTIGATION OF THE COMPUTER FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE FAILURE. CONFIRMED COMPLAINT. INSTALL IN SYSTEM IAS WOULD NOT TO CONNECT TO REMOTE DESK TOP. UNABLE TO RUN VIRUS SCAN. THE COMPUTER KEPT REBOOTING IN THE MIDDLE OF THE SCAN. DISCONNECTED ALL CONNECTIONS AND RECONNECTED. STILL KEPT REBOOTING IN THE MIDDLE IF THE SCAN. TIME AND DATE PASSED. SOFTWARE FUNCTIONALITY WAS THE FAILURE MECHANISM. (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 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 BIOMED SITE REPRESENTATIVE REPORTED THAT HE WAS INFORMED THAT THE IMAGING SYSTEM WAS NOT BOOTING UP COMPLETELY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO FURTHER DETAILS REGARDING THIS ISSUE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736476 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