BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6109927 · Received November 17, 2016

    Report

    Report Number
    1723170-2016-04074
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    April 13, 2015
    Report Date
    November 17, 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

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. FOUND INTERMITTENT PROBLEM WITH IMAGING SYSTEM GOING TO STAND ALONE MODE, LOSING PENDANT POWER, AND NOT COMMUNICATING ISSUES. REPLACED THE UMBILICAL CABLE. THE IMAGING SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE MOBILE VIEW STATION (MVS) INTERFACE CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION CONFIRMED COMPLAINT. MVS LOOP - OPEN WIRE BETWEEN BACK SIDE LEMO CONNECTOR (22) AND J2 PIN 2. GBIT PASSED, 100T PASSED. FAILED CONTINUITY TESTING. CABLE INSULATION IS IN EXCELLENT CONDITION. THE HARDWARE INVESTIGATION FOUND THAT REPORTED EVENT WAS RELATED TO AN ELECTRICAL FAILURE MODE; OPEN CABLE. (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 REPORTED THAT THE SITE INFORMED HER THAT WHEN THE IMAGING SYSTEM WAS BROUGHT INTO THE ROOM FOR A CASE ONE WEEK AGO, THE PENDANT WENT COMPLETELY BLACK. THE RADIOLOGIC TECHNOLOGIST (RT) UNPLUGGED/REPLUGGED THE UMBILICAL CABLE AND THE PENDANT WENT BACK TO NORMAL. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY DURING WHAT PROCEDURE AND IF THERE WAS ANY DELAY, WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760084 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