BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6087342 · Received November 8, 2016

    Report

    Report Number
    1723170-2016-03358
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    July 23, 2015
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION OF SYSTEM IDENTIFIED ISSUE RELATED TO 2D FLUORO ONLY WITH POSSIBLE BAD PIXEL COLUMNS ON DETECTOR PANEL. SEVERAL ATTEMPTS TO MASK FAILED TO COMPLETE DEFECT MAPPING. RETURNED TO SITE AND ATTEMPTED TO COMPLETE DEFECT MAPPING WITH RECONSTRUCTION OF BASE IMAGE. REPEATED CONSECUTIVE DEFECT MAP PROCESSES FOR EACH INDIVIDUAL COLUMN AND ACQUIRING NEW RAW IMAGE EACH TIME. SUCCESSFUL DEFECT MAPPING COMPLETED. PERFORMED IMAGE QUALITY TESTING WITH L/MM ACHIEVED 2.09 FOR NORMAL AND BOOST MODES. IMAGE TESTING WITH 1,2 AND 3 MM OF CU PLATES ACHIEVING MINIMUM OF 21 AND MAX OF 24 VISIBLE FEATURES. FLUORO/RAD GAIN CALIBRATIONS COMPLETED INVALIDATE HOME SEQUENCE COMPLETED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. PARTS WERE RETURNED UNUSED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE (B)(4) 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 SITE REPRESENTATIVE REPORTED THAT BIOMED REPORTED TO THEM THAT THE IMAGING SYSTEM IMAGES HAD LINES AND STREAKS THROUGH IT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO FURTHER DETAILS REGARDING THIS ISSUE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738295 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