BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE PACS

    MDR report key: 5544395 · Received April 4, 2016

    Report

    Report Number
    2183926-2016-00041
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K082144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MERGE PACS (PICTURE ARCHIVING COMMUNICATION SYSTEM) IS DESIGNED AND MARKETED FOR SOFT COPY READING, COMMUNICATION AND STORAGE OF STUDIES PRODUCED BY DIGITAL MODALITIES, INCLUDING DIGITAL MAMMOGRAPHY. ON (B)(6) 2013 A CUSTOMER REPORTED THAT A STUDY STATUS HAS BEEN CHANGED INCORRECTLY. THE LOGS REPORTED THAT THE STUDY WAS CHANGED BY A STAFF MEMBER; HOWEVER THE STAFF MEMBER DID NOT HAVE SYSTEM PERMISSIONS TO DO SO. MERGE HEALTHCARE IDENTIFIED THE ROOT CAUSE TO BE A DESIGN FLAW WHERE ANY USER WITH THE CHANGE WORKFLOW STATUS BUTTON CAN PDE ANY STUDY, EVEN IF THE USER DOES NOT HAVE PERMISSIONS TO USE THE PDE TOOL. THERE WAS NO REPORT OF PATIENT INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200583 MERGE PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ MERGE HEALTHCARE MERGE PACS V6.0 MR4

    Patients

    Seq Age Sex Outcome Treatment
    1