BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE UNITY PACS

    MDR report key: 5437775 · Received February 16, 2016

    Report

    Report Number
    2183926-2015-00429
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    July 7, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K041935
    Removal / Correction Number
    2183926-02/15/2016-037-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    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. (B)(6) HOSPITAL REPORTED THAT IF 2 IMAGES ARE CAPTURED FOR THE SAME VIEW AND EACH VIEW IS ASSOCIATED TO A TOMO IMAGE, BOTH TOMOS ARE ASSOCIATED TO THE FIRST OF THOSE TWO IMAGES. THE USER MAY MISS SEEING THE ADDITIONAL VIEW WHICH WOULD HELP WITH DIAGNOSIS. WHAT IS EXPECTED IS THE ABILITY TO VIEW TOMO ON FIRST RCC IMAGE AND ABILITY TO VIEW TOMO ON THE SECOND RCC IMAGE. WHAT IS HAPPENING IS THAT BOTH TOMOS ARE ASSOCIATED TO THE FIRST RCC IMAGE. THE SECOND RCC IMAGE HAS NO TOMO OPTION AVAILABLE. RELEASE 11.0 OF UNITY HAS A DEFECT WHICH MISSED THE ASSOCIATE OF THE SECOND TOMO. DESIGN AND TESTING FAILED TO DETECT THERE COULD BE MORE THAN 2 TOMO IMAGES FOR SAME VIEW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96708 MERGE UNITY PACS PACS LLZ MERGE HEALTHCARE 11.0

    Patients

    Seq Age Sex Outcome Treatment
    1