BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 4199395 · Received October 24, 2014

    Report

    Report Number
    1723170-2014-01141
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING COMPONENTS OF THE IMAGING SYSTEM WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS: X-RAY RELAY CONTROL BOARD. ATP CONSOLE BOARD. INTERFACE CONTROL BOARD. SYSTEM CONTROL BOARD. STANDALONE X-RELAY SERVICE KIT. THE COMPONENTS WERE FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND WHEN CONNECTED TO A TEST IMAGING SYSTEM. THE REPORTED EVENT WAS UNRELATED TO THESE COMPONENTS.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED THE SITE. THE FOLLOWING COMPONENTS OF THE IMAGING SYSTEM WERE SHIPPED TO THE SITE: STANDALONE-XRELAY, X-RAY RELAY CNTL BD, ATP CONSOLE, INTFC CTRL R F W/O HV, AND SYS CNTRL BD RWK. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO REPLACE THE COMPONENTS AND TEST THE EQUIPMENT. THE SYSTEM WAS CONFIRMED TO DISPLAY "CONNECTED NOT READY" MESSAGE ON THE PENDANT WHEN BOOTED. O-ARM APPLICATION SHOWED GENERATOR AND DETECTOR AS NOT READY. DURING TROUBLESHOOTING, FOUND ISOLATED STANDALONE PCB WAS NOT SUPPLYING 110 VAC TO POWER GENERATOR/ PAXSCAN PROCESSOR/ PLEORA. STANDALONE PCB HAD ONE LED, DL2, ILLUMINATED AND FANS WERE RUNNING. ORDERED, AND REPLACED ISOLATED STANDALONE PCB KIT (INCLUDING X-RAY RELAY/ VARISTOR AND RELAY CONTROL PCB). SYSTEM INITIALLY BOOTED NORMALLY UPON STANDALONE KIT REPLACEMENT. ON 2ND BOOT ATTEMPT, INITIAL SYMPTOMS REOCCURRED. AGAIN FOUND STANDALONE PCB WAS NOT SUPPLYING 110 VAC TO POWER ASSOCIATED COMPONENTS. PERFORMED ANOTHER REPLACEMENT OF STANDALONE PCB KIT. SYMPTOM UNRESOLVED WITH THIS REPLACEMENT. THROUGH TROUBLESHOOTING ISSUE SCHEMATICALLY, I SUSPECTED THAT STANDALONE PCB WAS NOT RECEIVING THE REQUIRED LOW SIGNAL FROM INTERFACE CONTROL PCB/ ATP PCB TO TURN ON, AND SUPPLY THE AC VOLTAGE TO POWER GENERATOR/ PAXSCAN. ORDERED, AND REPLACED INTERFACE CONTROL/ ATP PCB'S USING TECHNICAL INSTRUCTIONS. SYSTEM BOOTED NORMALLY. VERIFIED MAX DOSE AND PERFORMED SYSTEM CHECKOUT. AFTER REPLACING THE COMPONENTS, THE MECHANICAL AND IMAGING TESTS PASSED THE SYSTEM CHECKOUT. THE IMAGING SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE REPORTED ISSUE RECURRED ON (B)(6) 2014 DURING BOOT UP OUTSIDE OF SURGERY AND PRIOR TO PLANNED USE. A MEDTRONIC REPRESENTATIVE RETURNED TO THE SITE AND ATTEMPTED TO BOOT THE SYSTEM. THE PENDANT REMAINED IN "SYSTEM INITIALIZING" WITH THE X-RAY STATUS INDICATOR SHOWING GREEN BARS WITHOUT ACHIEVING "READY". X-RAY GENERATOR DID NOT BOOT, NOR DID THE PAXSCAN PROCESSOR. REMOTE DESKTOP SHOWED GENERATOR AND DETECTOR STATUS AS "NOT READY." THE REP TURNED SYSTEM OFF TO REMOVE GENERATOR COVERS/ OPEN GENERATOR DOORS FOR TROUBLESHOOTING. UPON NEXT SYSTEM BOOT TO TROUBLESHOOT, THE SYSTEM BOOTED NORMALLY INTO 2D MODE WITH THE ABILITY TO GENERATE X-RAYS. UNABLE TO REPLICATE THE ISSUE FURTHER. DUE TO THE INTERMITTENT NATURE OF THE SYMPTOM, AND THE INABILITY TO DISCOVER ANY LOOSE CONNECTIONS/OPEN WIRES THROUGH TROUBLESHOOTING, A SYSTEM CONTROL PCB WAS ORDERED AND REPLACED. SYSTEM TESTED, BOOTING NORMALLY WITH NUMEROUS ATTEMPTS. A SYSTEM CHECKOUT SHOWED THAT THE IMAGING SYSTEM WAS FULLY FUNCTIONAL. THE RETURNED STANDALONE-XRELAY COMPONENT FAILED DURING ELECTRICAL BENCH TEST WITH NO 110V AC OUTPUT. THE COMPONENT WAS CONFIRMED TO HAVE AN ELECTRICAL FAILURE MODE THAT CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WOULD NOT BOOT AND "CONNECTED NOT READY" WAS DISPLAYED ON THE PENDANT. THE SYSTEM WAS REBOOTED SEVERAL TIMES WITHOUT RESOLUTION. THE UMBILICAL CABLE WAS RECONNECTED WITHOUT RESOLUTION. AFTER A 15 MINUTE DELAY, THE IMAGING SYSTEM WAS ABORTED AND THE SURGEON CHOSE TO CANCEL THE SPINE FUSION SURGERY. THE PATIENT WAS UNDER ANESTHESIA BUT NO INCISION HAD BEEN MADE AT THE POINT THAT IT WAS DECIDE TO CANCEL THE SURGERY. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679568 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