BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 2222737 · Received July 29, 2011

    Report

    Report Number
    1525965-2011-00039
    Date Received
    July 29, 2011
    Report Date
    July 8, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A PT WITH DIPLOPIA AND PAPILLOEDEMA WAS GOING THROUGH A BRAIN SCAN. A CONTRAST ENHANCED CT BRAIN SCAN OF THE PT SHOWED PRESENCE OF POORLY DEFINED HYPO DENSITY REGIONS IN THE BRAIN. HOWEVER, THESE REGIONS COULD NOT BE IDENTIFIED ON SUBSEQUENT CONTRAST ENHANCED MRI SCAN. THE CUSTOMER BELIEVES THAT THE HYPO DENSITY REGIONS IN THE CT MAY BE AN ARTIFACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1