BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5849769 · Received August 5, 2016

    Report

    Report Number
    1723170-2016-01629
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    May 26, 2014
    Report Date
    August 5, 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. SEVERAL PART SHIPMENTS WERE PLACED FOR MANY PARTS. AFTER PART REPLACEMENT, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE FOLLOWING ARE RESULTS PART STATUS AND INVESTIGATION: PCBA PWR SWITCHING BOARD ASSY - COULD NOT CONFIRM REPORTED PROBLEM "BLOWS MOTOR RELAY". PWR SWITCHING BOARD WAS INSTALLED ON THE TEST SYSTEM AND WORKED WITHOUT ANY ISSUES. CABLE ASSY O-ARM CMPTR PWR - NO PROBLEM FOUND. CABLE WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. RELAY 12AMPS DC CTRL 0-200VDC - RELAY PIN 1 AND PIN 2 ARE SHORTED. VARISTOR MTL OXID 20MM 200VDC - PART NOT RETURNED, RETRIEVAL ATTEMPTS MADE. PCBA MOTOR BATTERY CHARGER - FAILED PCB LEVEL TEST. (CHANNEL D VOLTAGES 0); D9D IS SHORTED. L2D IS DAMAGED DUE TO ELECTRICAL OVER STRESS. CABLE J7 CHARGER CONN - RETURN UNUSED. PCBA MOTOR BATTERY CHARGER - LEAKING CAPACITORS ON THE BOARD. BOARD PASSED PCB LEVEL TEST. VARISTOR MTL OXID 20MM 200VDC - COULD NOT CONFIRM REPORTED PROBLEM. VARISTOR WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. RELAY 12AMPS DC CTRL 0-200VDC - CONFIRMED REPORTED PROBLEM "SHORTED". RELAY PIN 1 AND PIN 2 ARE SHORTED. PCBA PFC BOARD 1000 - COULD NOT CONFIRM REPORTED PROBLEM. PFC BOARD PASSED BENCH TEST. PFC BOARD WAS INSTALLED IN THE THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. PCBA PWR SWITCHING BOARD ASSY - CONFIRMED REPORTED PROBLEM "BLOWING MOTOR RELAY". DEFECTIVE PCBA. WHEN INSTALLED IN THE THE TEST SYSTEM IT BLEW UP MOTOR RELAY. MOTION CNTL BOX POSITIONER - COULD NOT CONFIRM REPORTED PROBLEM "CANNOT COMMUNICATE WITH IT". POSITIONER BOX WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. MOTION CNTL BOX GANTRY - COULD NOT CONFIRM REPORTED PROBLEM "DOOR WILL NOT CLOSE ALL THE WAY, AND OPENS DURING REHOME". GANTRY BOX WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. MOTION CNTL BOX ROTOR - NO PROBLEM FOUND. ROTOR BOX WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. FUSE 250V FAST 3AG 10A CART - PART NOT RETURNED, DISCARDED. COVER TILT STAGE COVER RIGHT - PART NOT RETURNED, DISCARDED. PCBA SYSTEM CTRL BOARD ASSY- WHEN SYSTEM CONTROL BOARD WAS INSTALLED ON THE SYSTEM, IT DIDN'T COMMUNICATE WITH THE GENERATOR. PCBA SYSTEM CTRL BOARD ASSY- COULD NOT CONFIRM REPORTED PROBLEM. SYSTEM CONTROL BOARD WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. PCBA PWR SWITCHING BOARD ASSY - RETURN UNUSED. RELAY 12AMPS DC CTRL 0-200VDC - CONFIRMED REPORTED PROBLEM "SHORTED". RELAY PIN 1 AND PIN 2 ARE SHORTED. MOTION CNTL BOX POSITION RWK -COULD NOT CONFIRM REPORTED PROBLEM. POSITIONER BOX WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. SVC KIT BI7 6 PACK BATTERY- PART NOT RETURNED, DISCARDED. 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. (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 USE OF THE O-ARM IMAGING SYSTEM WAS ABORTED. 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, WHILE IN A SPINE PROCEDURE, UPON START-UP, THE SITE'S IMAGING SYSTEM DISPLAYS A RED X AT MOTION CHECK. DURING THE PRE-CHECK, THE RED X WOULD NOT CLEAR FROM THE MOTION. THIS PREVENTED THE IMAGING SYSTEM FROM INITIALIZING AND STARTING UP PROPERLY. AS THE IMAGING SYSTEM WAS BEING MOVED INTO THE OPERATING ROOM, A LOUD POP WAS HEARD AS IF THEY HAD HIT SOMETHING, BUT NOTHING HAD BEEN RUN INTO. THE SYSTEM WAS RE-BOOTED SEVERAL TIMES, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE SURGEON DISCONTINUED USE OF THE IMAGING SYSTEM AND CHOSE TO COMPLETE THE PROCEDURE WITH A C-ARM, AN ALTERNATE SYSTEM. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A FORTY MINUTE DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION REPORTED FROM THE SITE INDICATED THAT THE MOBILE VIEW STATION (WORK STATION) IS NOT BOOTING UP PROPERLY WHEN CONNECTED TO THE IMAGE ACQUISITION SYSTEM, HOWEVER IT IS BOOTING-UP NORMALLY WHEN IT IS NOT CONNECTED TO THE IMAGE ACQUISITION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502005 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