BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6055765 · Received October 25, 2016

    Report

    Report Number
    1723170-2016-02744
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 25, 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

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE INSPECTED THE IMAGING SYSTEM ON-SITE. INVESTIGATION WAS UNABLE TO REPRODUCE THE ISSUE. BASED ON DESCRIPTION AND ERROR LOGS IT APPEARED THAT NETWORK COMMUNICATIONS WERE LOST BETWEEN THE IMAGING SYSTEM AND THE NAVIGATION SYSTEM. THE ETHERNET CABLE WAS DAMAGED IN SEVERAL PLACES AND DID NOT LATCH AT EITHER END. REPLACED THE CABLE SAVER AND SPOKE WITH SITE BIO-MED REGARDING REPLACING THE CABLE. THE SITE REPLACED THE ETHERNET CABLE AND THE ISSUE WAS RESOLVED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE IMAGING SYSTEM WAS UNABLE TO ACQUIRE A 3D SPIN. IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO ACQUIRE A CONFIRMATION 3D SPIN AT THE END OF THE PROCEDURE, THE USER HELD DOWN THE EXPOSURE BUTTON BUT A SPIN WAS NOT TAKEN. IT WAS REPORTED THAT THE MESSAGE "3D CONNECTED, NOT READY" WAS DISPLAYED WHEN THIS OCCURRED. THE SYSTEM WAS REBOOTED, AND UPON BOOT UP THE SYSTEM DISPLAYED THE MESSAGE "ERROR INITIALIZING COLLIMATOR" ON THE PENDANT. THE USE OF THE IMAGING SYSTEM AND MEDTRONIC NAVIGATION WAS DISCONTINUED BECAUSE OF THIS ISSUE. THERE WAS A REPORTED DELAY OF GREATER THAN ONE HOUR BECAUSE OF THIS ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF A SECOND IMAGING SYSTEM. THE PATIENT WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706673 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 69 YR