BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 17974935 · Received October 20, 2023

    Report

    Report Number
    17974935
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 6, 2023
    Manufacturer
    MERGE HEALTHCARE SOLUTIONS INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUR SITE SUPPORTS MERATIVE¿S MERGE CARDIO, WHICH IS A CARDIOLOGY PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM) SOLUTION FOR ULTRASOUND ECHOES AND FLUOROSCOPY CATHS. I BELIEVE IT IS ¿SOFTWARE AS A MEDICAL DEVICE¿ (510(K) # K192276). WE HAD AN ISSUE WITH THE SOLUTION. WE REPORTED THE ISSUE TO THE VENDOR. THE VENDOR HAS STATED THAT IT IS A KNOWN ISSUE THAT ANOTHER SITE HAS PREVIOUSLY REPORTED. THE VENDOR HAS NOT YET PROVIDED A WORKAROUND OR A SHORT-TERM PLAN. THEY HAVE SAID THEIR DEVELOPMENT TEAM IS REVIEWING THE ISSUE. THE ISSUE IS THAT WHEN A MOTHER WITH FETAL TWINS HAS AN ECHO PERFORMED, TWO SEPARATE STUDIES ARE PERFORMED UNDER THE MOTHER. WHEN THE REPORT FOR THE FIRST FETAL TWIN IS PERFORMED, NO ISSUES OCCUR IN THE MERGE CARDIO APPLICATION. WHEN THE REPORT FOR THE SECOND FETAL TWIN IS PERFORMED ON MERGE CARDIO, THERE IS A CHANCE THAT THE SECOND FETAL TWIN¿S REPORT IMPORTS THE FIRST TWINS¿ CARDIAC MEASUREMENTS. THESE IMPORTED VALUES APPEAR ON THE REPORT AND CANNOT BE REMOVED. WE PERFORM THESE STUDIES AT OUR SITE WITH REGULARITY, AND THIS IS THE FIRST TIME IT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996293 MERGE CARDIO SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ MERGE HEALTHCARE SOLUTIONS INC. 12.2

    Patients

    Seq Age Sex Outcome Treatment
    1 175 DA Unknown