BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6082115 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-04232
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 22, 2015
    Report Date
    November 7, 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 AGE NOT AVAILABLE FROM THE SITE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. CONFIRMED FAILURE DURING BENCH TESTING: CONTINUITY TEST FAILED - PIN 4 WIRE ON LEMO CONNECTOR IS BROKEN AT THE PIN. WHITE WIRE WITH THE BROWN TRACER IS BROKEN. THIS WAS CAUSED BY FAULTY UMBILICAL CONNECTOR SINCE IT WAS FOUND THAT THE BROWN WIRE HAS A COLD SOLDER. THE CABLE WAS REPLACED AND SYSTEM CHECKOUT TESTING PERFORMED. SYSTEM PASSED ALL TESTING. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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 DURING A CASE, THE MOBILE VIEW STATION (MVS) DISPLAYED A MESSAGE THAT IT WAS NOT CONNECTED TO THE STEALTH, BUT THE STEALTH SHOWED A GREEN LINE OF COMMUNICATION. THEY CLEARED THE MESSAGE AND PROCEEDED WITH THE CASE WITHOUT FURTHER ISSUE. THIS CAUSED A 5 MINUTE DELAY TO CASE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734002 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