BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5841516 · Received August 2, 2016

    Report

    Report Number
    1723170-2016-01758
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    September 8, 2014
    Report Date
    August 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. A MEDTRONIC REPRESENTATIVE VISITED THE SITE AND REPROGRAMMED THE MOTION CONTROLLER. THIS RESOLVED THE ISSUE AND THE SYSTEM WAS FULLY FUNCTIONAL AFTER REPROGRAMMING. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) DISTRICT OFFICE ON (B)(6) 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO (B)(6) 2016 FDA-(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 USE OF THE O-ARM IMAGING SYSTEM WAS ABORTED. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDR'S 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 SITE REPRESENTATIVE REPORTED THAT THE O-ARM WAS UNRESPONSIVE WHEN BOOTING. MVS (MOBILE VIEWING STATION) WAS RUNNING NORMALLY. THE 1ST GREEN BAR (MOTION ICON WITH GEAR WHEELS) WAS NOT LOADING ALL THE WAY. THE SURGEON PROCEEDED WITH THE SPINAL SURGERY WITHOUT USE OF THE O-ARM OR NAVIGATION. THE REP TRIED TO GET ERROR LOGS, BUT WHILE SAVING THEM THE SYSTEM BECAME UNRESPONSIVE AGAIN. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491957 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