BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1812771 · Received August 13, 2010

    Report

    Report Number
    2954704-2010-00009
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    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 INHOUSE. BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS REPORT, WE CANNOT CONFIRM THAT THE DEVICE WAS A FACTOR IN THE INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A CUSTOMER REPORTED THAT MEASUREMENTS FOR A LESION WERE DIFFERENT IN MAGNIFIED VIEW VERSUS REGULAR VIEW WHEN MEASURED IN ISITE PACS USING FUJI CR MAGNIFICATION. REGULAR VIEW SHOWS THE CORRECT MEASUREMENT. A LESION MEASURED IN ISITE PACS FROM SIEMENS MAMMOGRAPHY DR UNIT EQUALED 10MM. THE SAME LESION MEASURED ON STANDARD VIEW FROM FUJI CR EQUALED 10MM AND ON MAGNIFICATION VIEW FROM FUJI CR EQUALED 16MM. ISITE FOLLOWS THE DICOM STANDARD, SECTION 10.7 - BASIC PIXEL SPACING CALIBRATION MACRO WHEN CALCULATING MEASUREMENTS. FUJI IS NOT SENDING ANY DICOM INFORMATION FOR MAGNIFICATION OR CORRECTION OF PIXEL SPACING VALUES TO ACCOUNT FOR MAGNIFICATION IN THE MAGNIFIED VIEW IMAGES. THERE IS A MAGNIFICATION VALUE (0018, 1114) INCLUDED IN THE NON-MAGNIFIED VIEW OF THE FUJI STUDY.

    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