BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 6012923 · Received October 8, 2016

    Report

    Report Number
    2183926-2016-00759
    Event Type
    Malfunction
    Date Received
    October 8, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 8, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K051649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THE PULMONARY ARTERY Z-SCORES WERE CALCULATING CORRECTLY. HOWEVER, THE CUSTOMER WAS EXPECTING TO SEE BOSTON Z-SCORES FOR THE WHOLE VESSEL PULMONARY ARTERIES AND THE KNOWLEDGE BASE WAS USING CUSTOMER REQUESTED MICHIGAN Z-SCORES FOR THE PROXIMAL PULMONARY ARTERIES. THIS IS A USER ERROR AS THE CUSTOMER WAS ADDING DATA TO THE PROXIMAL PULMONARY ARTERY NODES AND GETTING CORRECT RESULTS FOR THE PROXIMAL PULMONARY ARTERIES BUT THEY WERE EXPECTING TO SEE WHOLE VESSEL PULMONARY ARTERY BOSTON ZSCORES. THE REPORTING ENGINEER REMOVED THE CUSTOM PROXIMAL PULMONARY ARTERY MEASUREMENTS NODES. NO PATIENTS RECEIVED INCORRECT CARE BASED ON THE OUTCOME OF THE CALCULATIONS.

    Description of Event or Problem · 1

    MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. ON (B)(6) 2016, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT THE PULMONARY ARTERY Z-SCORES WERE NOT CALCULATING AS EXPECTED IN THEIR ECHO.PEDS CLINICAL REPORT. WITH AN INCORRECT VALUE DISPLAYING IN THE DIAGNOSTIC REPORT, THERE IS A POTENTIAL FOR INCORRECT TREATMENT OF A PATIENT THAT COULD RESULT IN HARM. THE CUSTOMER INDICATED THAT THERE WERE NO PATIENTS THAT WERE TREATED INCORRECTLY BASED ON THE OUTCOME OF THE PERCEIVED INCORRECT VALUE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664295 MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS LLZ MERGE HEALTHCARE MERGE CARDIO V10.1.2

    Patients

    Seq Age Sex Outcome Treatment
    1