BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3805828 · Received April 29, 2014

    Report

    Report Number
    1525965-2014-00086
    Date Received
    April 29, 2014
    Report Date
    April 2, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR#(B)(4).

    Description of Event or Problem · 1

    IN THIS CASE, THE CUSTOMER REPORTED THAT THE QUALITY OF THE ITERATIVE MODEL RECONSTRUCTION (IMR) IMAGES WERE DISAPPOINTING. THE CUSTOMER REPORTED THAT THE IMR IMAGES DISPLAYED A THICK WALLS FOR ALL THE TUBE-LIKE STRUCTURES (IE.BRONCHI WALLS, AIRWAYS, ETC.) THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER. THE FSE STATED THAT THE IMAGES WERE RECONSTRUCTED WITH AN IMR PROTOTYPE IN BEST AND CONFIRMED THAT THE SYSTEM IS BRILLIANCE 64 WITH SOFTWARE VERSION 3.5.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256604 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1