BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1418516 · Received July 15, 2009

    Report

    Report Number
    2954704-2009-00010
    Event Type
    Other
    Date Received
    July 15, 2009
    Date of Event
    January 15, 2008
    Report Date
    January 15, 2008
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. WE ARE ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. PER INVESTIGATION AT TIME OF EVENT: ISITE PACS VERSION 3.3 TAKES CONSISTENT APPROACH OF USING IMAGER PIXEL SPACING FOR MEASUREMENT PERFORMED ON PROJECTION RADIOGRAPHY IMAGES. IMAGER PIXEL SPACING IS REQUIRED TO BE PRESENT IN PROJECTION RADIOGRAPHY IMAGES. THIRD PARTY MODALITY IS USING AN OPTIMAL DICOM TAG WHICH MAY OR MAY NOT BE PRESENT IN A GIVEN IMAGE. THE OPTIONAL DICOM TAG IN USE BY THE THIRD PARTY MODALITY ESTIMATES CONVERSION FROM IMAGER PIXEL SPACING INTO THE PT PIXEL SPACING. THE VALUE OF ESTIMATED RADIOGRAPHIC MAGNIFICATION FACTOR DOES NOT NECESSARILY RELATE TO THE PLANE IN WHICH MEASUREMENT IS PERFORMED. THE VALUE OF ESTIMATED RADIOGRAPHIC MAGNIFICATION FACTOR MAY OR MAY NOT BE PRESENT, DEPENDENT ON MODALITY CONFIGURATION. THE ONLY ACCURATE WAY TO GET PT MEASUREMENTS ON PROJECTION IMAGING IS TO USE FIDUCIAL MARKERS AND CALIBRATE MEASUREMENTS. THIS CAPABILITY IS SUPPORTED IN ISITE PACS. THE 3.3 IFU INCLUDES WARNINGS OF MODALITY DEPENDENT MEASUREMENTS AND THE STRONG RECOMMENDATION TO USE FIDUCIAL MARKERS FOR DETERMINING MAGNIFICATION FACTORS.

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED THAT MEASUREMENT IS INCONSISTENT WITH MEASUREMENT PERFORMED ON MODALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS ISITE PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1