BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6100958 · Received November 14, 2016

    Report

    Report Number
    1723170-2016-04553
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    April 16, 2015
    Report Date
    November 14, 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 FIELD SERVICE ENGINEER (FSE) WENT TO SITE TO TROUBLESHOOT ISSUE. IT WAS FOUND 3D IMAGES CONTAINED EXTENSIVE ARTIFACT NOT RESOLVED BY PERFORMING GAIN CALIBRATIONS. UTILIZED VARIAN VIVA SOFTWARE TO REMOVE PANEL DEFECTS WITHOUT SUCCESS. PERFORMED REPLACEMENT OF CP2 DETECTOR/ PAXSCAN PROCESSOR KIT. RESULTING TESTING SHOWED 2D/ 3D IMAGES THAT WERE ARTIFACT FREE. SYSTEM CHECKOUT PERFORMED WITH SATISFACTORY RESULTS. SYSTEM WAS PUT BACK INTO USE. THE DETECTOR KIT WAS SENT BACK TO THE MANUFACTURER FOR ANALYSIS. CONFIRMED REPORTED PROBLEM "IMAGE ARTIFACT IN 3D MODEL NOT RESOLVABLE WITH GAIN CALIBRATIONS". DETECTOR PANEL AND CP2 WERE INSTALLED IN THE O-ARM SYSTEM 267, IMAGE ARTIFACT IN 3D MODE WERE OBSERVED AS REPORTED. WHEN CP2 WAS REPLACED WITH A KNOWN GOOD CP2, IT CLEARED THE IMAGE ARTIFACT IN 3D. IMAGER ARTIFACT IN 3D MODE FOLLOWED THE DEFECTIVE CP2. NO FURTHER ISSUES REPORTED. 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 (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 FIELD SERVICE ENGINEER (FSE) REPORTED THE SYSTEM'S 3D HD IMAGES HAVE CYLINDRICAL ARTIFACT. THE 2D IMAGES LOOK GOOD. USING THE 3D PHANTOM THE FSE WAS ABLE TO REPLICATE THE ISSUE. A GAIN CALIBRATION WAS PERFORMED AND DEFECT MAPPING WITHOUT RESOLUTION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750787 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