BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 5995699 · Received October 4, 2016

    Report

    Report Number
    1723170-2016-02475
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 6, 2016
    Report Date
    November 30, 2016
    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

    INVESTIGATION OF RETURNED SUSPECT POWER SUPPLY PSI WAS UNABLE TO CONFIRM REPORTED PROBLEM. PERFORMED OUTPUT TESTING OVER THE COURSE AN HOUR. THE 5V SUPPLY DIDN'T FLUCTUATE BY MORE THAN 0.001VDC WHILE UNDER TEST. 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

    A MEDTRONIC FIELD SERVICE ENGINEER (FSE) PROACTIVELY REPLACED THE KIT SVC O2 POWER SUPPLY PSI. SYSTEM FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE POWER SUPPLY WAS DRIFTING. NO PATIENT PRESENT. NO EFFECT TO SYSTEM PERFORMANCE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649003 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1