BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5823692 · Received July 26, 2016

    Report

    Report Number
    1723170-2016-01700
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    August 3, 2015
    Report Date
    July 26, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO THE SITE TO TEST THE EQUIPMENT. THE CMOS BATTERY FAILURE CAUSED BIOS TO RESET. REPLACED CMOS BATTERY AND SET UP ALL THE BIOS SETTINGS. RELOADED THE SOFTWARE AS THE APPLICATION ON THE MVS WOULDN'T START UP. SUCCESSFUL SYSTEM CHECKOUT PERFORMED. THE SYSTEM IS READY FOR USE. (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 SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION CASE, THE O-ARM MVS WOULD NOT BOOT. THE USE OF MEDTRONIC IMAGING WAS DISCONTINUED DUE TO THIS ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A C-ARM AFTER A DELAY OF LESS THAN 1 HOUR. THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474747 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