BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE UNITY PACS

    MDR report key: 8431941 · Received March 19, 2019

    Report

    Report Number
    2183926-2019-00007
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 20, 2019
    Report Date
    February 20, 2019
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    UDI-DI
    00842000100331
    PMA / PMN Number
    K041935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MERGE UNITY PACS IS DESIGNED TO DISPLAY A MESSAGE TO THE USER WHEN AN EXAM REPORT FAILS TO UPLOAD TO THE IMAGE SERVER. IN THIS INSTANCE, THERE WAS NO EVIDENCE THAT THE PHYSICIAN RECEIVED THE MESSAGE WARNING THAT THE REPORT DID NOT UPLOAD. IT WAS NOT POSSIBLE TO DETERMINE IF THE MESSAGE DISPLAYED ON THE SCREEN FOR THE PHYSICIAN WHEN THE REPORT WAS FIRST READ AND SAVED. TROUBLESHOOTING FROM UNITY SUPPORT FOUND THAT THERE WAS A REPORT ID GENERATED, HOWEVER THE DOCUMENT WAS NOT UPLOADED TO THE IMAGE SERVER. A NEW MICROSOFT WORD TEMPLATE DOCUMENT WAS CREATED AND SUPPORT CREATED A NEW REPORT ID THAT WAS LINKED TO THE EXAM. THE EXAM WAS SENT BACK TO DICTATION ON HOLD (DIH) STATUS AND THE SITE CONFIRMED THAT THE EXAM WAS ABLE TO BE RE-READ WITHOUT INCIDENT. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    MERGE UNITY PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT IS USED FOR VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. ON (B)(6) 2019 THE CUSTOMER REPORTED AN EXAM WAS MARKED READ, HOWEVER, THERE IS NO EXAM REPORT. THE REPORT WAS SAVED, BUT NOT ASSOCIATED PROPERLY WITH THE EXAM. A CAUSE OF THE FAILED ASSOCIATION WAS NOT ABLE TO BE DETERMINED. AN INVESTIGATION SHOWED THE REPORT DID NOT UPLOAD SUCCESSFULLY AND HAD TO BE READ AGAIN BY THE DOCTOR. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT. HOWEVER, WHILE IMAGES ARE AVAILABLE, A FINALIZED REPORT NOT BEING AVAILABLE FOR SUBSEQUENT REVIEW BY THE PATIENT'S PHYSICIAN COULD POTENTIALLY RESULT IN A DELAY IN CARE THAT COULD LEAD TO HARM. REFERENCE SALES FORCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224311 MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM LLZ MERGE HEALTHCARE MERGE UNITY PACS R11.2.2 00842000100331

    Patients

    Seq Age Sex Outcome Treatment
    1