BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 16

    MDR report key: 2833809 · Received November 6, 2012

    Report

    Report Number
    1525965-2012-00090
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT, UNKNOWN ARTIFACTS THAT APPEAR ON ABDOMINAL STUDIES. THERE WAS NO MISINTERPRETATION, MISTREATMENT OR RESCAN OF A PT AS A RESULT OF THIS ARTIFACT AT THE CUSTOMER SITE. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, IF THIS ARTIFACT WERE TO RECUR, THERE IS POTENTIAL FOR MISINTERPRETATION WHICH COULD RESULT IN MISTREATMENT OF A PT. THIS REPORTED EVENT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 16 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728240

    Patients

    Seq Age Sex Outcome Treatment
    1