BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE EBW

    MDR report key: 2583123 · Received May 10, 2012

    Report

    Report Number
    1525965-2012-00023
    Date Received
    May 10, 2012
    Report Date
    April 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT THE TESTS DONE BY THEIR QUALITY AGENCY FOUND DIFFERENCES IN HOUNSFIELD VALUES WHEN DRAWING AN ROI BETWEEN THE IMAGES ON THE CT PART OF THE GEMINI SCANNER, ON THE PET/CT/HOST (EBW), AND ON THE EBW NM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE EBW JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728260

    Patients

    Seq Age Sex Outcome Treatment
    1