BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2

    MDR report key: 8066119 · Received November 13, 2018

    Report

    Report Number
    3004785967-2018-00330
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 13, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED FOR ANALYSIS AT THIS TIME. 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 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE ATTEMPTED TO USE THE SYSTEM BUT WERE UNABLE TO POWER ON THE MOBILE VIEW STATION (MVS) MONITOR. THE SYSTEM WAS REBOOTED TWICE WITHOUT RESOLUTION. THE LINE POWER LIGHT WAS ON AND THE POWER BUTTON WAS ILLUMINATED BLUE, BUT THEN WOULD GO TO ORANGE AFTER THE INITIAL BOOT UP SCREEN APPEARED. BOTH IMAGING AND NAVIGATION WERE ABORTED AND THE C-ARM WAS USED TO FINISH THE PROCEDURE. LATER IN THE WEEK THE SITE TRIED THE SYSTEM AGAIN BY REBOOTING THE MAV AND THE ISSUE RESOLVED, THE UNIT IS OPERATIONAL. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904880 O2 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR