BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5832109 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01516
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    November 30, 2015
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. EVENT PROBLEM AND EVALUATION: ON 1-DEC-2015, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. FOUND THE MOBILE VIEW STATION (MVS) COMPUTER NOT STARTING UP, HAD TO PRESS POWER BUTTON AFTER TURNING SWITCH. THE MVS COMPUTER CMOS BATTERY MEASURED .25 VDC. REPLACED BATTERY, CONFIGURED BIOS. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (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 DURING A SPINAL FUSION PROCEDURE, THE IMAGING SYSTEM¿S MOBILE VIEW STATION (MVS) WOULD NOT START UP. IN TROUBLE-SHOOTING, THE PENDANT SHOWED GREEN CHECKS FOR X-RAY AND MOTION BUT THE MVS HAD A RED X AND SHOWED ¿CONNECTED NOT READY.¿ THE LINE POWER LIGHT AND SYSTEM ON LIGHT WERE BOTH LIT ON THE MVS AND ABOUT THIRTY SECONDS AFTER BOOTING, THE FAN CAME ON BUT NOTHING DISPLAYED ON THE MVS SCREEN. THE REPORTED ISSUE COULD NOT BE RESOLVED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF ABOUT THIRTY MINUTES DUE TO THIS ISSUE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THE CASE WAS COMPLETED USING A C-ARM FOR IMAGING. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482280 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 66 YR