BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE ICT

    MDR report key: 3201143 · Received June 28, 2013

    Report

    Report Number
    1525965-2013-00185
    Date Received
    June 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL FILE A FOLLOW-UP NOR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM A CUSTOMER SITE THAT THE CUSTOMER WAS PERFORMING CARDIAC PROCEDURES ON THE CT SYSTEM AND REPORTED THAT, ON THREE DIFFERENT PATIENT EXAMS, SOME OF THE IMAGES EXHIBITED A MOTION ARTIFACT THAT COULD BE MISINTERPRETED AS AN AORTIC DISSECTION. THE TRAINED PROFESSIONAL RECOGNIZED THE MOTION ARTIFACT AND DETERMINED THAT IN TWO OF THE PATIENT EXAMS THE IMAGES COULD BE USED FOR INTERPRETATION. IN ONE OF THE PATIENT EXAMS THE TRAINED PROFESSIONAL DETERMINED THE IMAGES COULD NOT BE USED FOR INTERPRETATION AND THAT A RESCAN WAS NECESSARY. A PHILIPS RESEARCH SCIENTIST CONFIRMED THERE WAS NO MISINTERPRETATION OR MISTREATMENT OF A PATIENT DUE TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297208 BRILLIANCE ICT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1