BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6114893 · Received November 18, 2016

    Report

    Report Number
    1723170-2016-04552
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    February 12, 2015
    Report Date
    November 18, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO SITE TO TROUBLESHOOT ISSUE. IT WAS FOUND PENDANT STUCK AT INITIALIZING AS DESCRIBED IN COMPLAINT. MOTION STATUS "READY", BUT X-RAY STATUS SHOWS GREEN BARS ACROSS THE PENDANT SCREEN. CONNECTION TO REMOTE DESKTOP SHOWS X-RAY DETECTOR AS "NOT READY". GENERATOR POWERS ON. ALL FRAME GRABBER COMPONENTS POWERED ON. PAXSCAN COMPUTER HAS YELLOW LIGHT ILLUMINATED FOR FIBER CONNECTION. DETECTOR FIBER CONNECTION HAS GREEN LIGHT ILLUMINATED. REPLACEMENT OF PAXSCAN PROCESSOR PERFORMED. SYSTEM SUBSEQUENTLY BOOTS UP NORMALLY, AND SUCCESSFULLY ABLE TO ACQUIRE IMAGES. MOBILE VIEW STATION (MVS) INTERCONNECT CABLE REPLACED PER PROCEDURE DURING RESOLUTION OF ISSUE. SYSTEM CHECKOUT PERFORMED WITH SATISFACTORY RESULTS. CABLE AND COMPUTER WERE SENT BACK TO MANUFACTURER FOR EVALUATION. COULD NOT CONFIRM REPORTED PROBLEM. PAXSCAN CP2 WAS INSTALLED IN TEST SYSTEM AND RAN WITHOUT ANY ISSUES. COULD NOT CONFIRM REPORTED PROBLEM. UMBILICAL CABLE PASSED BENCH LEVEL TEST, AND RAN WITHOUT ANY ISSUES. NO FURTHER ISSUES REPORTED. (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 REPRESENTATIVE CALLED TO REPORT AN ISSUE WITH THE IMAGING SYSTEM INITIALIZATION. TROUBLESHOOTING IMAGING SYSTEM SAYS "INITIALIZING SYSTEMS. PLEASE WAIT" AND CANNOT GET IT TO MOVE OUT OF OR PAST THIS STATE. IN THE MOBILE VIEW STATION (MVS) APPLICATION IT SAYS THE GENERATOR IS READY BUT DISPLAYS "DETECTOR NOT READY". THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765340 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