BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6071085 · Received November 1, 2016

    Report

    Report Number
    1723170-2016-03639
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    January 13, 2016
    Report Date
    November 1, 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 FOUND THAT THE ERROR LOGS DID NOT SPECIFY THE ISSUE. THOUGH THE ROTOR DID NOT HOME PROPERLY AND WAS THE LIKELY CAUSE OF THE REPORTED ISSUE. A CALIBRATION OF THE ROTOR WAS PERFORMED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE MOTION CONTROL BOX WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE MOTION CONTROL BOX WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE SOFTWARE FUNCTIONED AS DESIGNED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE 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 MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION. AFTER A SUCCESSFUL 3D SPIN WITH THE IMAGING SYSTEM, THE GANTRY DOOR WOULD NOT OPEN PROPERLY TO REMOVE FROM OVER THE PATIENT. INITIAL TROUBLESHOOTING WAS PERFORMED BY MANUALLY OPENING THE DOOR AND REMOVING THE UNIT FROM THE ROOM. AFTER THE EVENT, THEY WERE UNABLE TO REPLICATE THE REPORTED ISSUE. 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
    722296 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 65 YR