BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICONNECT ENTERPRISE ARCHIVE

    MDR report key: 5438200 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00152
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    January 26, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LMB
    PMA / PMN Number
    NONE. EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Description of Event or Problem · 1

    CUSTOMER OF ICONNECT ENTERPRISE ARCHIVE REPORTED TO OUR SUPPORT TEAM THAT XA STUDIES RETRIEVED FROM THE LTA WERE DISPLAYING IN THE VIEWER AS JUST A BLACK SCREEN. THIS IS OCCURRING FOR ALL STUDIES THAT HAVE STORED TO THE ARCHIVE AND BEEN DELETED FROM THE EXCELERA LOCAL FILE SYSTEM SINCE (B)(6) 2014. THUS, PRIORS CAN NOT BE VIEWED. MULTI-FRAME IMAGES RETRIEVED FROM THE LTA APPEAR ALL BLACK IN THE VIEWER. CAUSE: IN (B)(6) 2013 A CUSTOM ENGINEERING MORPHER WAS PUT IN PLACE ON THE LONG TERM ARCHIVE (LTA) TO HANDLE ISSUES WITH A GE DEVICE THAT WAS SENDING THE LTA BAD DICOM WHICH CAUSED THE CLARCS TO CRASH. THE MORPHER WAS INTENDED TO MODIFY THESE OBJECTS TO ALLOW THEM TO STORE TO THE LTA WITHOUT ISSUE. THE MORPHER INADVERTENTLY CAUSED THE ARCHIVE TO STREAM THE PIXEL DATA OF ALL INCOMING IMAGES TWICE. THIS PRESENTS A PROBLEM IN THE ARCHIVE STORE CODE SPECIFICALLY FOR MULTI-FRAME IMAGES THAT ARRIVED NATIVE AND WERE COMPRESSED TO JPEG2K BY THE LTA. WHEN ATTEMPTING TO COMPRESS THESE MULTI-FRAMES THE ARCHIVE WOULD ATTEMPT TO STREAM THE PIXEL DATA AGAIN AND SINCE IT WAS ALREADY STREAMED ONCE INVALID PIXEL DATA WAS IDENTIFIED. THIS LEFT THE IMAGE IN A STATE WHERE ALL FRAMES OF THE PIXEL DATA TAG WOULD HAVE THE SAME VALUE (PRESENT BLACK IN A VIEWER). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94857 ICONNECT ENTERPRISE ARCHIVE IMAGE ARCHIVE LMB MERGE HEALTHCARE 8.80.1

    Patients

    Seq Age Sex Outcome Treatment
    1