BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5849762 · Received August 5, 2016

    Report

    Report Number
    1723170-2016-01639
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    October 6, 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

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, THE MEDTRONIC REPRESENTATIVE, DEDUCED THAT PARTS RELATED TO THE BATTERY CHARGER REQUIRED REPLACEMENT. REPLACEMENT PARTS, GREEN LED CABLE ASSEMBLY, BATTERY CHARGER1 PCBA, BATTERY CHARGER2 PCBA AND MOTOR BATTERY CHARGER PCBA WERE REQUESTED AND SHIPPED TO THE SITE. AFTER REPLACING THE PARTS, THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE GREEN LED CABLE ASSEMBLY, BATTERY CHARGER1 PCBA, BATTERY CHARGER2 PCBA AND MOTOR BATTERY CHARGER PCBA WERE RETURNED TO MEDTRONIC FOR ANALYSIS. AN ON-SITE INVESTIGATION WAS COMPLETED ON THE RETURNED PARTS. GREEN LED CABLE ASSEMBLY- CONFIRMED REPORTED PROBLEM "NOT WORKING." LED IS NON-FUNCTIONAL. BATTERY CHARGER1 PCBA- CONFIRMED REPORTED PROBLEM. BATTERY CHARGER 1 FAILED BOARD LEVEL BENCH TEST. CHANNEL G OUTPUT FAILED FROM NO LOAD TO FULL LOAD CHANNEL G OUTPUT IS STUCK AT 0V. DEFECTIVE PCBA -ELECTRICAL. BATTERY CHARGER2 PCBA - COULD NOT CONFIRM REPORTED PROBLEM. BATTERY CHARGER 2 BOARD PASSED PCB LEVEL BENCH TEST. A SIMULATED USE TEST WAS PERFORMED. BATTERY CHARGER 2 WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. NO FAULT FOUND. MOTOR BATTERY CHARGER PCBA- COULD NOT CONFIRM REPORTED PROBLEM. MOTOR BATTERY CHARGER BOARD PASSED BENCH LEVEL TEST. A SIMULATED USE TEST WAS PERFORMED. MOTOR CHARGER BOARD WAS INSTALLED IN THE TEST SYSTEM AND RAN WITHOUT ANY ISSUES. NO FAULT FOUND. REPORTED ISSUE WAS DUE TO A DEFECTIVE BATTERY CHARGER1 BOARD AND GREEN LED CABLE ASSEMBLY. 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 IN A SPINE PROCEDURE BUT PRIOR TO MOVING THE SYSTEM INTO THE ROOM, A LOUD POP WAS HEARD FROM THE SITE'S IMAGING SYSTEM. THE IMAGING SYSTEM WAS SHUT DOWN AND RESTARTED. THE MEDTRONIC REPRESENTATIVE TESTED THE SYSTEM FUNCTIONALITY AND MOVED THE SYSTEM INTO THE ROOM TO CONTINUE WITH IMAGING. 2D FLUORO IMAGES WERE TAKEN WITH NO ISSUE. THE IMAGING SYSTEM EMITTED THE POPPING SOUND AGAIN, AND THE SURGEON OPTED TO CONTINUE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THE SURGERY WAS SUCCESSFULLY, COMPLETED. THERE WAS A FIFTY FIVE MINUTE DELAY TO THE PROCEDURE DUE TO REMOVING THE IMAGING SYSTEM AND MANUALLY REGISTERING THE PATIENT. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501601 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 73 YR