BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE PACS

    MDR report key: 6165569 · Received December 11, 2016

    Report

    Report Number
    2183926-2016-00816
    Event Type
    Malfunction
    Date Received
    December 11, 2016
    Date of Event
    November 11, 2016
    Report Date
    February 22, 2017
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K082144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE REPORTED ISSUE FOUND THAT MERGE PACS IS FUNCTIONING AS DESIGNED. THE COMMENTS WERE NOT BEING SAVED AS THAT SPECIFIC COMMENT SECTION IS FOR DOCUMENTING ADDITIONAL INFORMATION FOR WHEN AND WHY A STATUS IS CHANGING. THE COMMENTS DO NOT SAVE WHEN THE STATUS IS NOT CHANGED.

    Additional Manufacturer Narrative · 1

    MERGE HEALTHCARE IS CONTINUING TO INVESTIGATE THE ISSUE AND WILL DETERMINE IF CORRECTIONS OR CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    MERGE PACS IS A PICTURE ARCHIVING COMMUNICATION SYSTEM THAT IS INTENDED TO CREATE AND DISPLAY TWO-DIMENSIONAL AND THREE-DIMENSIONAL IMAGES OF ANATOMY FROM A SERIES OF DIGITALLY ACQUIRED IMAGES. PACS IS DESIGNED AND MARKETED FOR SOFT COPY READING, COMMUNICATION, AND STORAGE OF STUDIES PRODUCED BY DIGITAL MODALITIES. ON (B)(6) 2016 A CUSTOMER REPORTED THAT THE COMMUNICATION NOTES WERE NOT SAVING. WITH MERGE PACS NOT SAVING COMMUNICATION NOTES AS EXPECTED THERE IS A POTENTIAL FOR A DELAY IN DIAGNOSIS OR TREATMENT THAT LEADS TO HARM. THE CUSTOMER DID NOT ALLEGE AN INJURY, THE NEED FOR MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES AS A RESULT OF THE UNRETRIEVABLE IMAGES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816189 MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS LLZ MERGE HEALTHCARE MERGE PACS 7.0.2

    Patients

    Seq Age Sex Outcome Treatment
    1