BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 6033626 · Received October 17, 2016

    Report

    Report Number
    6033626
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    August 27, 2016
    Report Date
    September 16, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNOLOGIST WAS TRYING TO REBOOT THE COMPUTER ON THE CT SCAN AT THE TIME THE SCANNER BECAME UNRESPONSIVE. (B)(4) WAS CALLED FOR SERVICE, AND A TECHNICIAN CAME ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684709 BRILLIANCE 64 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1