BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6104604 · Received November 15, 2016

    Report

    Report Number
    1723170-2016-03340
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    July 28, 2014
    Report Date
    November 15, 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 REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. A REPLACEMENT UMBILICAL WAS SHIPPED TO THE SITE. AFTER REPLACING THE UMBILICAL, THE MEDTRONIC REPRESENTATIVE PERFORMED AN SYSTEM CHECKOUT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. AN INVESTIGATION WAS COMPLETED AT THE MEDTRONIC FACILITY WHICH CONFIRMED THE REPORTED EVENT WAS CAUSED BY AN ELECTRICAL ISSUE. THERE WAS A BROKEN CABLE WIRE AT PIN 2. A REPLACEMENT DOOR WINCH REPLACEMENT KIT WAS SHIPPED TO THE SITE AND RETURNED UNUSED ON 08/11/2014. (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 AFTER BOOTING UP THE IMAGE ACQUISITION SYSTEM (IAS), THE SYSTEM PENDANT SHOWED 'SYSTEM BOOTING, PLEASE WAIT.' THE MEDTRONIC REPRESENTATIVE RESTARTED THE IAS. THIS TIME, THE COMMUNICATION LINE WAS BROKEN AND ORANGE (NOT GREEN). WHEN THE SYSTEM BOOTED UP, THE PENDANT SAID 'WAITING FOR MOBILE VIEW STATION (MVS) TO INITIATE CONNECTION.' THE PENDANT SHOWED THIS MESSAGE FOR 5 MINUTES. THE SURGEON THEN DECIDED TO USE THE SITE'S 2ND IMAGING SYSTEM TO COMPLETE THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE 2ND IMAGING SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753093 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 46 YR