BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS SERVER

    MDR report key: 3190707 · Received June 24, 2013

    Report

    Report Number
    3004526608-2013-00004
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Report Date
    January 21, 2013
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K110875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THERE ARE MULTIPLE INTERPRETATIONS OF THE DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) STANDARD REGARDING ANATOMICALLY ZOOMED IMAGES. THE HEADER FIELDS ESTIMATED RADIOGRAPHIC MAGNIFICATION FACTOR (ERMF) (0018, 1114), IMAGER PIXEL SPACING (0018, 1164) AND PIXEL SPACING (0028, 0030) ARE BEING USED DIFFERENTLY TO CALCULATE THE ZOOM FACTOR OF THESE IMAGES, CAUSING THE MEASUREMENTS TO BE INCORRECT ON CERTAIN IMAGES. THE CENTRICITY PACS IS COMPLIANT WITH THE DICOM STANDARD, HOWEVER, IT DOES NOT USE THE ALGORITHMS SPECIFIED IN THE INTEGRATING THE HEALTHCARE ENTERPRISE (IHE) STANDARD FOR CALCULATING DISTANCE AND AREA MEASUREMENTS. THIS CAUSES IMAGES THAT FOLLOW THE IHE STANDARD TO DISPLAY ON THE CENTRICITY PACS AS NOT CALIBRATED. THE ROOT CAUSE OF THIS ISSUE IS DETERMINED TO BE A COMBINATION OF THREE CAUSES: USE ERROR WITH NOT CALIBRATING OR CALIBRATING INCORRECTLY WHEN PERFORMING MEASUREMENTS WITH XA IMAGES THAT CONTAIN A MAGNIFICATION FACTOR; THE DIFFERENCE IN DICOM IMPLEMENTATION ACROSS VENDORS AND PRODUCTS AND; THE PRIMARY ROOT CAUSE IS THE PACS VIEWER DISPLAYING INFORMATION INCORRECTLY BECAUSE THE ERMF DATA IS NOT USED WITH DISTANCE MEASUREMENTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DISCREPANCY BETWEEN MEASUREMENTS FROM A THIRD PARTY ANGIO MODALITY AND PACS WORKSTATION (RA1000, CWEB). THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286364 PACS SERVER LLZ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1