BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 8915984 · Received August 21, 2019

    Report

    Report Number
    3004785967-2019-01495
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI30000554, SERIAL/LOT #: REV. 1 (B)(4). THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM. THE REPORTED ISSUE WAS CONFIRMED AND THE SYSTEM INITIALIZING PLEASE WAIT. THEY FOUND THE IMAGE ACQUISITION SYSTEM (IAS) COMPUTER NOT TURNING ON. THE BIOS SETTINGS WERE CORRECT. THE WINDOWS GOT A BLUE SCREEN WHEN BOOTING. THEY COULD NOT RELOAD THE SOFTWARE. THEY REPLACED THE IAS COMPUTER, UPDATED CONFIG FILES. A SYSTEM CHECKOUT WAS PERFORMED AND THE SYSTEM WAS WORKING AS INTENDED. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS CONFIRMED. THE IAS COMPUTER FAILED BENCH TEST AND THE HARD DRIVE MALFUNCTIONED. THE WINDOWS RECEIVED A BLUE SCREEN AND THE WINDOWS LOGON PROCESS WAS TERMINATED UNEXPECTEDLY, THE SYSTEM SHUT DOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WILL NOT FULLY BOOT. THE MOBILE VIEW STATION (MVS) BOOTS WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708778 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000027120

    Patients

    Seq Age Sex Outcome Treatment
    1