BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYS BI70002000 O-ARM SYS O2

    MDR report key: 8821400 · Received July 24, 2019

    Report

    Report Number
    3004785967-2019-01300
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 28, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE NETWORK CONNECTOR AND THE RIGHT DOOR SWITCH WERE REPLACED. THE LEFT DOOR SWITCH WAS ADJUSTED AND THE ISSUE WAS RESOLVED. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS HAVING VAGUE ISSUES, INCLUDING THE USER GETTING "UNABLE TO CONNECT TO GAIN CONNECTION PATH," THE BLUE LIGHT FOR THE GRID WAS NOT INDICATING "AP/LATERAL" (NOT MATCHING), AND THE ETHERNET CABLE COULD NOT BE REMOVED OUT OF THE BACK OF THE MACHINE. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614311 BASE SYS BI70002000 O-ARM SYS O2 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1