BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 2222807 · Received August 9, 2011

    Report

    Report Number
    1525965-2011-00041
    Date Received
    August 9, 2011
    Report Date
    July 14, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT AND THEREFORE CANNOT COMPLETE SECTIONS AT THIS TIME. WE WILL FILE A F/U MDR UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE WAS UNABLE TO DETECT LOW CONTRAST LIVER LESIONS ON BRILLIANCE 64 SYS. HE WAS UNABLE TO VISUALIZE LESIONS THAT WERE PREVIOUSLY IDENTIFIED FOR THE SAME PT ON OTHER SCANNERS. THE CUSTOMER ALSO ALLEGED THAT HE HAD TO RECONSTRUCT USING MULTIPLE FILTERS AND ENHANCEMENT LEVELS IN ORDER TO SEE THE SAME LOW CONTRAST DETECTABILITY WHEREAS ONLY ONE FILTER, AND ONE RECONSTRUCTION WAS NEEDED WITH OTHER SCANNERS. THERE WAS NO REPORT OF MISDIAGNOSIS OR MISTREATMENT.

    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