BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6116420 · Received November 21, 2016

    Report

    Report Number
    1723170-2016-04317
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    May 5, 2014
    Report Date
    November 21, 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

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE TESTING CONFIRMED THE REPORTED COMMUNICATION ISSUE. THE REPRESENTATIVE THEN REPLACED THE DETECTOR PANEL AND THE ETHERNET PORT ON THE SYSTEM. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE ETHERNET PORT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PORT WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE DETECTOR PANEL WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. TESTING FOUND THAT THE 3D ARTIFACTS WOULD DISAPPEAR AFTER A GAIN CALIBRATION, BUT WOULD REAPPEAR AFTER A FEW DAYS. THIS CONFIRMED AN ELECTRICAL FAILURE DUE TO THE 3D ARTIFACTS. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 (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 MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE WAS UNABLE TO TRANSFER A 3D SPIN FROM THE IMAGING SYSTEM TO THE NAVIGATION SYSTEM. THE 3D IMAGE APPEARED TO BE ALL WHITE WITH NO ANATOMY PRESENT. RESTARTING THE SYSTEM AND TAKING A NEW PHOTO RESOLVED THE REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769429 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