BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6057558 · Received October 26, 2016

    Report

    Report Number
    1723170-2016-03277
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 3, 2014
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPRESENTATIVE CALLED AND REPORTED THAT THE 2D ACQUIRED IMAGES WHERE OF POOR QUALITY. THE REP TURNED OFF THE AUTO-BRIGHTNESS FEATURE AND PROCEEDED WITH THE CASE. AFTER THE INCIDENT, THE FIELD SERVICE ENGINEER (FSE) WAS CONTACTED TO SCHEDULE AN ONSITE VISIT. THE FSE REVIEWED THE IMAGES AND FOUND THAT THEY COULD STILL BE USED THOUGH THE 2D IMAGES HAD MANY PIXELATED HORIZONTAL LINES. A FLUORO GAIN CALIBRATION WAS PERFORMED WHICH DID NOT FIX THE ISSUE. THE DETECTOR AND PAXSCAN PROCESSOR ALONG WITH THE LVDS CABLE WHERE REPLACED. AFTER THE REPLACEMENT, A SYSTEM CHECKOUT WAS PERFORMED SUCCESSFULLY WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. THE PAXSCAN AND THE LVDS CABLE WERE SENT TO THE MANUFACTURER FOR ANALYSIS, HOWEVER THE CABLE WAS NEVER RECEIVED. ANALYSIS OF THE PAXCAN CONFIRMED THE REPORTED FAILURE. THE DETECTOR DISPLAYED A STOP WEDGE IMAGE WHEN 2D FLUOROS WERE TAKEN. FURTHERMORE, 2D IMAGES HAD MANY PIXLATED HORIZONTAL AND VERTICAL LINES. THE ISSUE COULD NOT BE CORRECTED WITH CALIBRATION. AN ELECTRICLE FAILURE MODE WAS CONFIRMED VIA A DEFECTIVE DETECTOR PANEL. 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

    THE SITE REPRESENTATIVE CALLED AND REPORTED THAT THE 2D ACQUIRED IMAGES WHERE OF POOR QUALITY. THE REP TURNED OFF THE AUTO-BRIGHTNESS FEATURE AND PROCEEDED WITH THE CASE. AFTER THE INCIDENT, THE FIELD SERVICE ENGINEER WAS CONTACTED TO SCHEDULE AN ONSITE VISIT. A PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708182 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