BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6105536 · Received November 16, 2016

    Report

    Report Number
    1723170-2016-04079
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    November 24, 2015
    Report Date
    November 16, 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 COLYX WOULD CLOSE BUT NOT OPEN. REPLACED COLLIMATOR AND ROTOR MOTION CONTROLLER. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE COLLIMATOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION UNABLE TO CONFIRM REPORTED PROBLEM "ERROR INITIALIZING COLLIMATOR. COULD NOT MOVE COLX WHEN HAVING MOTION CONTROLLER AT RUN LEVEL =8." IT WAS NOTED THE SHIPPING BRACKETS WERE NOT INSTALLED. INSTALLED COLLIMATOR ON HEUSTIS FIXTURE AND IT COMPLETED BENCH TESTING SUCCESSFULLY. INSTALLED COLLIMATOR ON IMAGING SYSTEM AND IT OPERATED AS EXPECTED. NO INITIALIZATION OR MOVEMENT ERRORS. NO FAULT FOUND. THE HARDWARE INVESTIGATION OF THE ROTOR MOTION CONTROLLER WAS UNABLE TO CONFIRM REPORTED PROBLEM "ERROR INITIALIZING COLLIMATOR. COULD NOT MOVE COLX WHEN CONTROLLER WAS SET AT RUN LEVEL =8." INSTALLED MOTION CONTROLLER IN IMAGING SYSTEM AT THE SAME TIME AS ASSOCIATED COLLIMATOR AND THE START UP, INCLUDING INITIALIZATION OF THE COLLIMATOR WAS NORMAL. SEVERAL POWER CYCLES, INVALIDATING HOME, AND MOTION CALIBRATIONS PERFORMED OVER 3 DAYS OF USE, AND NO ERRORS WERE OBSERVED. NO FAULT FOUND. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) 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 BIOMED SITE REPRESENTATIVE REPORTED THAT HE RECEIVED THE ERROR: INITIALING COLLIMATOR FROM THE IMAGING SYSTEM. WHILE TROUBLESHOOTING HE TURNED OFF THE SYSTEM, UNPLUGGED UMBILICAL CORD, TURNED THE SYSTEM BACK ON, AND PLUGGED IN THE UMBILICAL CORD. THE ISSUE HAS PERSISTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758715 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