BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5972153 · Received September 22, 2016

    Report

    Report Number
    1723170-2016-03444
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    April 11, 2014
    Report Date
    September 22, 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

    ON 14-MAR-2014, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE MOBILE VIEW STATION (MVS) COMPUTER AND MONITOR WERE REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE MOBILE VIEW STATION (MVS) SERVER COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, AND AN ELECTRICAL FAILURE MODE WAS FOUND DURING TESTING. COMPUTER HAD VIDEO OUTPUT BUT WOULD NOT BOOT BECAUSE HAS OF WRONG SETTINGS ON BIOS BOOT ORDER. THERE WAS ALSO AN ORANGE LIGHT IN FRONT OF THE SERVER, INDICATING A DEPLETED (B)(6) BATTERY. THE BATTERY WAS ONLY 2.7V (SHOULD BE ABOUT 3.2V). ALSO, THE DIMM MEMORY WAS READING ONLY 1GB (SHOULD BE 3GB). THE FLAT SCREEN DISPLAY (30 IN) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, AND AN ELECTRICAL FAILURE MODE WAS CONFIRMED DURING TESTING. THE MONITOR HAD NO POWER. 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 MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN HE TURNED ON THE IMAGING SYSTEM, THE MONITOR ON THE MOBILE VIEW STATION (MVS) WAS BLACK; NO IMAGES APPEARED AT ANY POINT. THE IMAGE ACQUISITION SYSTEM (IAS) PENDANT DISPLAYED ¿CONNECTED BUT NOT READY, WAITING FOR MVS TO INITIATE COMMUNICATION.¿ IN TROUBLE-SHOOTING, THE SYSTEM WAS RE-BOOTED AND ALL CABLES WERE CONFIRMED TO BE PROPERLY CONNECTED, BUT THIS DID NOT RESOLVE THE ISSUE. NO PATIENT WAS PRESENT WHEN THIS EVENT OCCURRED, SO NO PATIENT DEMOGRAPHICS ARE APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622027 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