BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6119065 · Received November 21, 2016

    Report

    Report Number
    1723170-2016-04360
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    June 11, 2015
    Report Date
    November 21, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 SYSTEM. A REPLACEMENT IMAGE ACQUISITION SYSTEM (IAS) PENDANT CONTROL WAS SHIPPED TO THE SITE. AFTER REPLACING THE IAS PENDANT CONTROL, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. AN INVESTIGATION WAS COMPLETED AT THE MEDTRONIC FACILITY WHICH CONFIRMED THE REPORTED EVENT WAS CAUSED BY A ELECTRICAL ISSUE WITHIN THE IAS PENDANT CONTROL. THE PENDANT WAS INSTALLED IN THE IAS SYSTEM 267. THE PENDANT WOULD INTERMITTENTLY FREEZE ON A BLANK WHITE SCREEN AND NOT COMPLETE THE BOOT UP PROCESS. THE ISSUE WAS INTERMITTENT, AND RESTARTING THE SYSTEM WOULD FIX THIS ISSUE. (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, FOLLOWING UP WITH THE SITE, REPORTED THAT THE MAIN PENDANT WOULD NOT RESPOND. THE SITE ATTEMPTED TO USE THE 2ND PENDANT, HOWEVER, THE 2ND PENDANT FROZE, TOO. THE USER THEN TOOK A 2D IMAGE. IMMEDIATELY AFTER THAT, THE MOBILE VIEW STATION (MVS) DISPLAYED THE IMAGE WITH A HIGH SPEED CLOCKWISE ROTATION. THEY REBOOTED THE IMAGE ACQUISITION SYSTEM (IAS) AND THE MOBILE VIEW STATION (MVS). AFTER THE REBOOT, THE SYSTEM WORKED WITHOUT ANY ISSUES. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE 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
    767739 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