BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE CT SCANNER CARDIAC VIEWER SOFTWARE

    MDR report key: 922411 · Received October 2, 2007

    Report

    Report Number
    1525965-2007-00023
    Event Type
    Malfunction
    Date Received
    October 2, 2007
    Date of Event
    May 15, 2007
    Report Date
    May 17, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    1525965-09/11/07-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUES WERE DISCOVERED DURING POSTPROCESSING AND REVIEW OF PREVIOUSLY ACQUIRED DATA. THIS INITIAL REPORT FROM ONE SITE COULD NOT BE REPRODUCED THROUGH TESTINGS AT THE SITE AND TESTS AT THE FACTORY. BASED ON THE INFORMATION AVAILABLE AT THAT TIME, PHILIPS MEDICAL SYSTEMS DETERMINED THAT THIS WAS NOT AN MDR REPORTABLE EVENT. SUBSEQUENT TO THIS REPORT, A SECOND REPORT OF A SIMILAR NATURE WAS SENT TO PHILIPS MEDICAL SYSTEMS. MDR 1525965-2007-00005 WAS FILED. UPON REVIEW OF THE COMPLAINT FILES, PHILIPS MEDICAL SYSTEMS DETERMINED THAT IT WAS LIKELY THAT THESE TWO REPORTED EVENTS ARE THE SAME, AND A DECISION WAS REACHED TO ALSO FILE AN MDR ON THE FIRST REPORTED EVENT.

    Description of Event or Problem · 1

    A PROBLEM HAS BEEN DISCOVERD WITH DISTANCE MEASUREMENTS ON IMAGES FROM THE PHILIPS CT SCANNER. WHEN A SERIES OF IMAGES IS MAGNIFIED BY THE RADIOGRAPHERS AT THE CT CONSOLE (AS FOR A THORACIC AORTA COMPUTED TOMOGRAPHY ANGIOGRAPHY STUDY), THE PIXEL CALIBRATION THAT COMES FROM THE CT SCANNER APPEARS TO BE INCORRECT AND AS A CONSEQUENCE, MEASUREMENTS MADE FROM A PACS WORKSTATION ARE INACCURATE FOR THESE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE CT SCANNER CARDIAC VIEWER SOFTWARE VIEWING APPLICATION FOR CT IMAGES JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR