BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL VIEWER

    MDR report key: 5025168 · Received August 24, 2015

    Report

    Report Number
    3004526608-2015-00002
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    GE HEALTHCARE IT
    Product Code
    LLZ
    PMA / PMN Number
    K150420
    Removal / Correction Number
    FMI 85413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THERE ARE MULTIPLE PRIMARY ROOT CAUSES THAT LED TO THE REPORTED ISSUE: 1. DIFFERENCE IN DICOM IMPLEMENTATION ACROSS VENDORS AND PRODUCTS 2. LOGIC ERROR IN THE USAGE OF DICOM TAGS IN THE UNIVERSAL VIEWER PRODUCT FOR DIGITAL PROJECTION MODALITIES. 3. REQUIREMENTS ARE LACKING DETAILS. 4. CROSS-FUNCTIONAL COMMUNICATION. 5. INSUFFICIENT DICOM CONFORMANCE STATEMENT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DISTANCE MEASUREMENTS MAY NOT BE CALCULATED ACCURATELY BY THE UNIVERSAL VIEWER WHEN APPLIED TO IMAGES ACQUIRED WITH A MAGNIFICATION FACTOR ON SIEMEN'S XA MODALITY (ANGIOGRAPHY X-RAY IMAGES) . DURING A PRODUCT DEMONSTRATION OF THE UNIVERSAL VIEWER WEB 6.0 , A RADIOLOGIST MEASURED VALUES ONSCREEN EQUALING TO 1.36CM AND 1.31CM, WHEN THE ACTUAL MEASUREMENTS SHOULD HAVE BEEN AROUND 1CM. IF NOT NOTICED BY THE CAREGIVER, THIS COULD LEAD TO AN OVERESTIMATE OF THE ANATOMY OF INTEREST. WHEN A MODALITY SENDS IMAGES TO PACS THAT ONLY CONTAIN VALUES IN THE IMAGER PIXEL SPACING (0018, 1164) , AND MAGNIFICATION FACTOR (0018, 1114) DICOM TAGS, BUT DO NOT INCLUDE A VALUE IN THE PIXEL SPACING (0020,0030) DICOM TAG THE MEASUREMENTS MAY BE INCONSISTENT WITH THE MAGNIFICATION FACTOR RESULTING A DISCREPANCY IN THE MEASUREMENTS DISPLAYED ON THE VIEWER. GE RECOMMENDS THAT USERS INCLUDE AN APPROPRIATELY PLACED OBJECT OF KNOWN SIZE IN THE IMAGE TO BE USED FOR CALIBRATION THAT WILL ALLOW USERS TO OBTAIN ACCURATE DISTANCE MEASUREMENTS. UPON CALIBRATION THE MEASUREMENTS ARE CORRECT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558785 UNIVERSAL VIEWER SYSTEM, IMAGE PROCESSING, RADIOLOGIC LLZ GE HEALTHCARE IT N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1