BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6063908 · Received October 28, 2016

    Report

    Report Number
    1723170-2016-03289
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    November 12, 2014
    Report Date
    October 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE MOBILE VIEW STATION (MVS) WOULD NOT TURN ON AFTER BRINGING IT INTO A ROOM. NO PATIENT WAS PRESENT. AN ONSITE INVESTIGATION WAS SCHEDULED FOR A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715533 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1