BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6107837 · Received November 16, 2016

    Report

    Report Number
    1723170-2016-04516
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    June 25, 2015
    Report Date
    November 16, 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. NUMEROUS PARTS WERE ORDERED AND SENT TO SITE. REPLACED UMBILICAL CABLE, AND FAILED PLEORA, THEN TESTED SYSTEM FOR IMAGE CLARITY AND TRANSFER TO IMAGING SYSTEM. ALSO, THE FSE COMPLETED 2015 PM CHECKS AND ADJUSTMENTS. REPLACED MOTION BATTERIES, MVS UPS BATTERY PACK, AND UPGRADED MVS ETHERNET PORT KIT. CHECKED IMAGE TRANSFER BETWEEN IMAGING SYSTEMS. ALL TESTING PASSED AND SYSTEM FUNCTIONED AS INTENDED. MOBILE VIEW STATION (MVS) CABLE AND PLEORA WERE SENT BACK TO MANUFACTURER FOR EVALUATION. CABLE CONFIRMED REPORTED COMPLAINT "NO CONTACT TO MVS, FRAME RATE ERROR." MVS INTERFACE CABLE (WHITE WIRE) IS BROKEN NEAR THE BODY OF THE CONNECTOR. MVS INTERFACE CABLE FAILS BENCH TESTING. PLEORA CONFIRMED REPORTED PROBLEM "PLEORA FAILURE. DEFECTIVE PLEORA BOX. NO FURTHER ISSUES REPORTED. 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) CALLED TO REPORT THAT THE SITE WAS RECEIVING GRAINY IMAGES FROM THE FIRST AP SHOT. TROUBLESHOOTING THE FSE REQUESTED A NUMBER OF PART FOR REPLACEMENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756757 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