BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION

    MDR report key: 7205592 · Received January 19, 2018

    Report

    Report Number
    7205592
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    October 19, 2017
    Report Date
    January 5, 2018
    Manufacturer
    CANON MEDICAL SYSTEMS USA, INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CT UNIT LOCKED UP AND SHUTDOWN HALFWAY THROUGH SCAN. SECOND SCAN RESULTED IN DEVICE SHUTTING DOWN AGAIN. PATIENT WAS GIVEN CONTRASTS DURING BOTH TESTS. MANUFACTURER RESPONSE FOR CT SCANNER, (BRAND NOT PROVIDED) (PER SITE REPORTER). RESPONDED TO SERVICE REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50791 AQUILION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEMS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO| NO OTHER THERAPIES