BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLANCE 64

    MDR report key: 2222806 · Received August 9, 2011

    Report

    Report Number
    1525965-2011-00040
    Date Received
    August 9, 2011
    Report Date
    July 18, 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 H1, H9 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 SEEING A MASS OVER THE LEFT LOBE IN THE LIVER, NEAR THE GASTRIC AIR BUBBLE. THE CUSTOMER ALSO ALLEGED THAT THE "MASS" WAS NOT REAL ANATOMY AND COULD BE A SCANNER ARTIFACT. THERE WAS NO REPORT OF MISDIAGNOSIS OR MISTREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1