BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6095899 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-03477
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    May 1, 2014
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    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. THE IMAGING SYSTEM FAILED IMAGING MODALITIES. DETECTOR NOT READY. FOUND CP1 PAXSCAN NOT COMMUNICATING WITH DETECTOR. REPLACED CP1 WITH CP2 PAXSCAN AND DETECTOR. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF THE DETECTOR PANEL CONFIRMED REPORTED PROBLEM "FOUND CP1 PAXSCAN NOT COMMUNICATING WITH DETECTOR" . THIS PART NUMBER CONSISTS OF 3 PARTS LISTED BELOW. " DETECTOR PANEL, " CP1, " POWER SUPPLY. DURING INVESTIGATION 3 PARTS WERE INSTALLED IN THE IMAGING SYSTEM; DETECTOR PANEL HAD RED LED ON. WHEN CP1 AND POWER SUPPLY WERE REPLACED WITH A KNOWN GOOD CP2, DETECTOR PANEL POWERED UP OK AND COMMUNICATED WITH CP2. THE HARDWARE INVESTIGATION FOUND A DEFECTIVE CP1. FAILURE MODE WAS ELECTRICAL; NO POWER. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6)DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (B)(6). 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 RADIOLOGIC TECHNOLOGIST (RT) FROM THE SITE REPORTED THAT WHILE ATTEMPTING TO SET-UP FOR A CASE WHEN THE IMAGING SYSTEM PENDANT SHOWED SCROLLING PROGRESS BARS FOR THE X-RAY COMPONENT THAT WOULDN'T INITIALIZE. SHE TRIED REBOOTING TWICE AND ONCE MORE OVER THE PHONE WITH NO CHANGE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747285 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