BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5836869 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01750
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    June 24, 2015
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED BY THE SITE REPRESENTATIVE. A SOFTWARE INVESTIGATION WAS COMPLETED AND COULD NOT FIND ANY PROBLEMS WITH THE SOFTWARE AFTER SYSTEM LOG ANALYSIS. HOWEVER, A MEDTRONIC FIELD SERVICE ENGINEER RELOADED SYSTEM BOARD FIRMWARE THEN TESTED THE BOOT SEQUENCE 3 TIMES, ALL WITHOUT ERROR. ISSUE RESOLVED WITH FIRMWARE RELOAD.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WORDING WAS ACCIDENTALLY OMITTED ON THE INITIAL REPORT. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO (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 HOSPITAL BIOMED REPRESENTATIVE REPORTED THAT THE O-ARM WAS NOT MOVING CORRECTLY. RADIOLOGY TECH REPORTED THAT EVERY TIME THEY ATTEMPTED USE OF THE SYSTEM THEY HAVE TO REBOOT THE SYSTEM TO GET THE O-ARM WORKING PROPERLY. THERE WAS MINIMAL DELAY (LESS THAN AN HOUR). THE SYSTEM STOPPED WORKING AT THE END OF THE SPINE SURGERY. THEY COULDN'T GET IT TO MOVE FOR THE FINAL CONFIRMATION SPIN. THEY BROUGHT IN A PORTABLE X-RAY FOR A FILM INSTEAD. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489044 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