BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 6116611 · Received November 21, 2016

    Report

    Report Number
    1723170-2016-05483
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 21, 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE INSPECTED THE IMAGING SYSTEM ON-SITE. IT WAS FOUND THAT THE GROUND FAULT INTERRUPTER (GFI) WAS INTERMITTENTLY TRIPPING. THE GFI WAS UPGRADED AND THE ISSUE WAS RESOLVED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769714 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1