BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE UNITY PACS

    MDR report key: 13502481 · Received February 9, 2022

    Report

    Report Number
    2183926-2022-00004
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 9, 2022
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    UDI-DI
    00842000100744
    PMA / PMN Number
    K041935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MERGE HEALTHCARE INVESTIGATED THE ISSUE IDENTIFIED BY A MERGE UNITY PACS SOFTWARE COMPONENT SUPPLIER, FOVIA INC. FOVIA'S REQUIREMENT TO CHECK FOR SQUARE OR EQUAL X AND Y PIXELS, PRIOR TO RENDERING DICOM COMPLIANT 3D IMAGE DATASETS, WAS NOT FULLY IMPLEMENTED IN THEIR SOFTWARE TOOLKIT. FOVIA PERFORMED THEIR OWN INVESTIGATION AND DID NOT FIND ANY CUSTOMER/USER COMPLAINTS FOR NON-SQUARE PIXELS IN 3D RENDERED IMAGES OVER THE PAST 18 YEARS. FOVIA SEARCHED THEIR IMAGE DATABASE, AMASSED OVER 18 YEARS, AND DID NOT FIND A SINGLE 3D RENDERABLE DATASET WITH NON-SQUARE PIXELS. MERGE HEALTHCARE ANALYZED OVER 12 YEARS OF SERVICE RECORDS AND COMPLAINTS AND WAS UNABLE TO FIND A SINGLE INSTANCE OF A CUSTOMER OR USER WITH AN ISSUE RELATED TO 3D IMAGES WITH NON-SQUARE PIXELS. MERGE HEALTHCARE ALSO ANALYZED INTERNAL IMAGING DATABASES AND COULD NOT FIND ANY 3D RENDERABLE DATASETS WITH NON-SQUARE PIXELS. FOVIA'S COMPLAINANT IDENTIFIED THE MISSING REQUIREMENT BY USING A NON-SQUARE PIXEL 3D RENDERABLE DATASET THAT WAS MATHEMATICALLY MANIPULATED. BETWEEN FOVIA AND MERGE HEALTHCARE, NEITHER COMPANY COULD FIND ANY REAL-WORLD CLINICAL/MEDICAL 3D RENDERABLE IMAGING DATASETS WITH NON-SQUARE PIXELS. WHILE THERE IS A POTENTIAL OF NON-SQUARE 3D RENDERABLE IMAGES EXISTING IN THE FIELD FOR CT, MR, PT AND A FEW OTHER IMAGING DATASET TYPES, NO ACTUAL REAL-WORLD EVIDENCE WAS FOUND. RESEARCH INTO MEDICAL IMAGING DESIGN AND STANDARDS ALSO INDICATED THAT NON-SQUARE X,Y PIXELS IN 3D DICOM COMPLIANT IMAGE DATASETS IS ATYPICAL. IF REAL-WORLD MEDICAL IMAGING 3D DATASETS WITH NON-SQUARE PIXELS WERE GENERATED IN THE VIEWER, THERE IS A POTENTIAL THAT DIAGNOSTIC OR TREATMENT DECISIONS MAY BE INACCURATE DUE TO IMAGE DISTORTION OR INCORRECT MEASUREMENTS. NEITHER FOVIA OR MERGE HEALTHCARE HAVE HAD ANY ALLEGATIONS FROM USERS INDICATING OR ALLEGING THAT PATIENTS WERE INJURED OR HARMED DUE TO DIAGNOSTIC OR TREATMENT DECISIONS BEING MADE IN THE 3D VIEWER. CLINICIANS MAY RENDER IMAGES IN 3D FOR IMPROVED VISUALIZATION OF THE PATIENT'S ANATOMY OR A SPECIFIC REGION OF INTEREST (ROI). HOWEVER, STANDARD CLINICAL PRACTICE IS TO MEASURE A PATIENT'S ANATOMY OR REGIONS OF INTEREST IN 2D. MERGE HEALTHCARE'S RESOLUTION FOR THE MISSING FOVIA REQUIREMENT IS TO ADD A SCREENING CHECK TO MERGE UNITY PACS. THIS CHECK WILL PREVENT DICOM COMPLIANT 3D IMAGE DATASETS WITH NON-SQUARE X,Y PIXELS FROM BEING RENDERED FOR VIEWING IN FOVIA'S TOOKLIT. NO FURTHER ACTION IS INDICATED.

    Description of Event or Problem · 0

    MERGE UNITY PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT ALLOWS VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. MERGE UNITY PACS INTERFACES TO VARIOUS STORAGE AND PRINTING DEVICES USING DICOM OR SIMILAR INTERFACE STANDARDS. MERGE UNITY PACS DISPLAYS, STORES, PRINTS, AND TELECOMMUNICATES IMAGES FROM A NUMBER OF MEDICAL MODALITIES, INCLUDING BUT NOT LIMITED TO MRI, CT, US, PET, DXA (BONE DENSITOMETRY), NUCLEAR IMAGING, COMPUTED RADIOGRAPHY, DIGITAL RADIOGRAPHY, DIGITIZED FILMS, DIGITAL PHOTOGRAPHS AND MAMMOGRAPHIC IMAGES. ON 1/11/2022, MERGE HEALTHCARE RECEIVED AN EMAIL NOTIFICATION FROM AN APPROVED SUPPLIER, FOVIA MEDICAL INC. FOVIA PROVIDES A 3D MEDICAL IMAGING SOFTWARE TOOLKIT THAT IS USED WITH MERGE UNITY PACS TO RENDER DICOM COMPLIANT 3D IMAGES FOR VIEWING. THE EMAIL PROVIDED INFORMATION REGARDING A REQUIREMENT THAT WAS NOT FULLY IMPLEMENTED WITHIN FOVIA'S 3D MEDICAL IMAGING TOOLKIT. THE REQUIREMENT IS THAT: X AND Y PIXEL SPACING MUST BE EQUAL FOR DATA LOADED INTO 3D IMAGE RENDERING ENGINES. PER FOVIA, "ALTHOUGH CROSS SECTIONAL 3D IMAGING DATA ALMOST ALWAYS HAS EQUAL X & Y SPACING AS ADDITIONAL ASSURANCE, AND TO PROTECT FROM THE RARE EVENTS THEY ARE NOT EQUAL, OUR NEXT RELEASE OF THE SDK WILL NOW NOT ALLOW THIS DATA TO LOAD INTO 3D RENDER ENGINES (2D RENDER ENGINES WILL CONTINUE TO SUPPORT IT)." MERGE HEALTHCARE HAS RECEIVED NO COMPLAINTS FROM CUSTOMERS OR USERS OF MERGE UNITY PACS REGARDING THE RENDERING OF NON-SQUARE X,Y PIXEL 3D IMAGES. MERGE HEALTHCARE, IN CONVERSATIONS WITH FOVIA MEDICAL, LEARNED THAT THE MISSING REQUIREMENT WAS IDENTIFIED BY A CUSTOMER/OEM THAT USES FOVIA'S 3D IMAGING TOOLKIT. THIS CUSTOMER WAS DOING RESEARCH AND DEVELOPMENT (R&D) ON A FEATURE UNRELATED TO 3D IMAGE RENDERING. TO PERFORM THEIR R&D ACTIVITIES, FOVIA'S CUSTOMER CREATED A DERIVED MATHEMATICAL PHANTOM DATASET. WHEN THIS MATHEMATICALLY MANIPULATED IMAGE DATASET WAS RENDERED IN FOVIA'S 3D VIEWER, THE IMAGE WAS OBSERVED TO BE OUT OF PROPORTION. THERE IS A POTENTIAL THAT DIAGNOSTIC OR TREATMENT DECISIONS MADE FROM 3D IMAGES WITH UNEQUAL OR NON-SQUARE X,Y PIXELS MAY BE INCORRECT DUE TO IMAGE DISTORTION & INACCURATE MEASUREMENTS. THERE ARE NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT CN-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777175 MERGE UNITY PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS LLZ MERGE HEALTHCARE 12.0.8 00842000100744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown