BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 7298989 · Received February 27, 2018

    Report

    Report Number
    1723170-2018-00889
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 31, 2018
    Report Date
    June 22, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PENDANT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AFTER FUNCTIONAL TESTING, VISUAL AND PHYSICAL EXAMINATION, THE REPORTED ISSUE WAS CONFIRMED THAT THE BUTTONS ARE INTERMITTENTLY HARD TO PRESS. AFTER THE VISUAL INSPECTION IT WAS FOUND THAT THE LAMINATION WAS COMING OFF THE PENDANT. THE PENDANT WAS REPLACED AND THE SYSTEM WAS FUNCTIONING AS INTENDED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE INSPECTED THE IMAGING SYSTEM ONSITE AND CONFIRMED THE ISSUE. THE PENDANT WAS REPLACED AND THE ISSUE RESOLVED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED FOLLOWING PART REPLACEMENT AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, AFTER TAKING THE FIRST ANTERIOR POSTERIOR (AP) FLUORO IMAGE, THE PENDANT SHOWED THE KV VALUE DROPPED TO 0KV. THE RADIOLOGIC TECHNOLOGIST (RT) ADJUSTED THE KV ON THE IMAGING SYSTEM'S PENDANT AND ATTEMPTED TO MOVE THE SYSTEM GANTRY TO A LATERAL POSITION. THE PENDANT SWITCHED TO M2D MODE WITHOUT THE RT PRESSING THE BUTTON TO DO SO. THE RT THEN ATTEMPTED TO MOVE THE SYSTEM GANTRY POSITION MORE TOWARDS THE PATIENT'S HEAD, BUT THE SYSTEM GANTRY TILTED INSTEAD. THE SITE WAS ABLE TO CAPTURE THE 2D AND 3D IMAGES NEEDED FOR THE PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 5 MINUTES DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142607 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON) 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR