BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5843828 · Received August 3, 2016

    Report

    Report Number
    1723170-2016-01532
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    November 19, 2015
    Report Date
    August 3, 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

    EVENT PROBLEM AND EVALUATION: ON (B)(6) 2015, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AND FOUND AN IMAGING FAILURE MODE WITH THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER. THE IAS COMPUTER WAS REPLACED, AND THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE FOLLOWING PART WAS RETURNED TO THE MANUFACTURER WITH FUNCTIONAL PROBLEMS THAT DIRECTLY CAUSED THE REPORTED EVENT: THE IMAGING SYSTEM COMPUTER WAS RETURNED FOR ANALYSIS AND A COMPUTER FAILURE MODE WAS FOUND. THE COMPUTER PASSED VIRUS SCAN, AND HAD A CMOS BATTERY REPLACED DUE TO LOW MEASURED VOLTAGE OF .207 VOLTS. A NEW CMOS BATTERY WAS INSTALLED, AND CMOS AND BIOS SETTINGS WERE RE-SET. INSTALLED COMPUTER IN SIMILAR IMAGING SYSTEM, AND IT FUNCTIONED AS EXPECTED, SUCCESSFULLY ACQUIRING 2D AND 3D IMAGES WHEN INITIATED. THE REPORTED EVENT WAS ATTRIBUTED TO A DEPLETED CMOS BATTERY. THE FOLLOWING PART WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, THE PART DID NOT CAUSE THE REPORTED EVENT AND/OR NO FUNCTIONAL PROBLEM WAS FOUND: THE POWER SWITCHING BOARD ASSEMBLY PCBA WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, NO PROBLEM WAS FOUND. THE PART WAS REPLACED WITH THE IAS COMPUTER, BUT STILL OPERATED AS EXPECTED WHEN INSTALLED IN A SIMILAR IMAGING SYSTEM. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) 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 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 SETTING UP THE IMAGING SYSTEM FOR A SPINAL FUSION CERVICAL PROCEDURE, THE MOBILE VIEW STATION (MVS) CART BOOTED UP BUT THE IMAGE ACQUISITION SYSTEM (IAS) SHOWED "SYSTEM BOOTING PLEASE WAIT" ON THE SCREEN. IN TROUBLE-SHOOTING, THE USER ATTEMPTED TO ENTER THROUGH THE REMOTE DESKTOP ON THE MVS BUT WAS UNABLE TO CONNECT TO THE IAS. UNPLUGGING THE UMBILICAL CABLE AND RE-STARTING THE IAS SEPARATELY DID NOT RESOLVE THE ISSUE. THE IAS WOULD NOT GET PAST THE "SYSTEM BOOTING PLEASE WAIT" SCREEN. AT THAT TIME, THE ERROR COULD NOT BE RESOLVED; THEREFORE, THE SITE WAS UNABLE TO USE THE IMAGING SYSTEM AND THE SURGERY WAS CANCELED. THE SYSTEM ERROR WAS FOUND PRE-OPERATIVELY, PRIOR TO BRINGING THE PATIENT INTO THE OPERATING ROOM. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. FURTHER TROUBLE-SHOOTING INCLUDED PULLING THE LOGS, WHICH INDICATED THE "HOST UNREACHABLE" ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494866 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 50 YR