BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 2950414 · Received February 5, 2013

    Report

    Report Number
    1525965-2013-00014
    Date Received
    February 5, 2013
    Report Date
    January 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT THE CUSTOMER REPORTED A WHITE AND CIRCULAR ARTIFACT APPEARING IN A PEDIATRIC PATIENT'S IMAGES. THE TRAINED PROFESSIONAL COULD NOT DETERMINE IF THE ARTIFACT WAS TRULY A PATHOLOGY SO THE PATIENT WAS SENT FOR AN MRI STUDY TO VERIFY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48131 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1