BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 6109822 · Received November 17, 2016

    Report

    Report Number
    1723170-2016-02976
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 20, 2016
    Report Date
    September 29, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE GFI FOR THE IMAGING SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    THE GFI FOR THE IMAGING SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE USER TERMINATED A SPIN PRIOR TO COMPLETION, AND THEN A BEEPING SOUND COULD BE HEARD COMING FROM THE IMAGE ACQUISITION SYSTEM (IAS). A SYSTEM REBOOT WAS ATTEMPTED, BUT A RED 'X' WAS THEN DISPLAYED FOR THE GENERATOR STATUS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760580 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1