BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 5834535 · Received July 29, 2016

    Report

    Report Number
    1723170-2016-01852
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    January 14, 2016
    Report Date
    July 29, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    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. THE IMAGING SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. HE RECOMMENDED TO THE SITE, THAT IF THIS SHOULD HAPPEN AGAIN THEN TO TRY THE FOOT SWITCH TO RULE OUT AN INTERMITTENT ISSUE WITH THE HAND SWITCH. THE SOFTWARE LOGS INDICATE 4 UNSUCCESSFUL ATTEMPTS TO TAKE A 3D SCAN. ONE ATTEMPT APPEARS TO BE ABORTED BY THE USER AND THE OTHER 3 WERE A RESULT OF AN ¿XRAY SIGNAL STATE. CONDITION: INIT TIMEOUT¿ ERROR. THE ISSUE COULD BE HARDWARE RELATED BUT THERE IS NOT SUFFICIENT INFORMATION IN THE LOGS TO DETERMINE THIS. THE SOFTWARE INVESTIGATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. (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 THEY WERE UNABLE TO DO A 3D SPIN. THE REP WAS TOLD THAT THEY WERE ABLE TO SUCCESSFULLY DO AN AP SHOT. THE SURGEON DISCONTINUED USE OF THE IMAGING SYSTEM AND COMPLETED THE CASE WITH A CONVENTIONAL C-ARM WITH NO DELAY. THERE WAS NO CLINICAL IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485285 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR