BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE PACS

    MDR report key: 6062727 · Received October 27, 2016

    Report

    Report Number
    2183926-2016-00776
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K082144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS NOT EXPERIENCED THIS ISSUE SINCE THE (B)(6) WAS UPDATED. NO FURTHER ACTIONS WERE TAKEN BY MERGE HEALTHCARE AND THE INVESTIGATION IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, MERGE SUPPORT FOUND THE JAKARTA SOFTWARE WAS GIVING ACCESS VIOLATIONS WHEN THE SERVER WAS LOADED WITH 3 OR MORE CONCURRENT USERS. MERGE SUPPORT WAS ABLE TO UPDATE THE CUSTOMER'S SOFTWARE, WHICH RESOLVED THE ISSUE. AT THIS TIME, MERGE HEALTHCARE IS CONTINUING THEIR INVESTIGATION AND WILL DETERMINE IF ANY FURTHER 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 THREEDIMENSIONAL 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 THEY WERE UNABLE TO LOGIN INTO MERGE PACS FOR APPROXIMATELY 8 HOURS. RATHER THAN USING MERGE PACS, PHYSICIANS AND RADIOLOGISTS WERE ABLE TO VIEW IMAGES AND PATIENT STUDIES AT THE IMAGING MODALITY. WITH CLINICIANS NOT BEING ABLE TO LOG INTO MERGE PACS THERE IS A POTENTIAL FOR A DELAY IN TREATMENT OR DIAGNOSIS. HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO DIRECT IMPACT TO PATIENT CARE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713607 MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS LLZ MERGE HEALTHCARE MERGE PACS 6.6.3.1

    Patients

    Seq Age Sex Outcome Treatment
    1