BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 5998947 · Received October 4, 2016

    Report

    Report Number
    2183926-2016-00749
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 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 LEFT MAIN CORONARY ARTERY UNIT OF MEASURE WAS LISTED IN MM. THIS WAS CAUSING THE Z-SCORE TO INCORRECTLY CALCULATE. ONCE THE UNIT OF MEASURE FOR LEFT MAIN CORONARY ARTERY WAS UPDATED FROM MM TO CM, THE KNOWLEDGE BASE CORRECTLY CALCULATED THE Z-SCORE. AS A WORK AROUND, THE CUSTOMER ELECTED TO UTILIZE ANOTHER DEVICE TO CALCULATE THE Z-SCORE THAT. IN MERGE CARDIO, THE DEFAULT UNIT OF MEASURE FOR CORONARY ARTERIES IN THE 3.4 AND 3.5 ECHO.PEDS KNOWLEDGE BASES IS CM, THIS CUSTOMER REQUESTED TO HAVE THEIR KB TO HAVE THE CORONARY ARTERIES UNIT OF MEASURE AS MM. THIS CUSTOMIZATION CAUSED THE Z-SCORES TO CALCULATE DIFFERENTLY THAN EXPECTED. THE REPORTING ENGINEER HAS CORRECTED THE ISSUE AND THE CUSTOMER CONFIRMED IN THE TEST ENVIRONMENT PRIOR TO MOVING TO PRODUCTION. THE CUSTOMER HAS CONFIRMED CORRECT RESULTS IN PRODUCTION. THE CUSTOMER WAS CONTACTED AND 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 ALLEGING THAT THE LEFT CORONARY ARTERY Z-SCORES WERE NOT CALCULATING CORRECTLY IN THEIR ECHO.PEDS CLINICAL REPORT. DUE TO 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 WAS CONTACTED AND NO PATIENTS WERE TREATED INCORRECTLY BASED ON THE OUTCOME OF THE INCORRECT VALUE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650136 MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS LLZ MERGE HEALTHCARE MERGE CARDIO V10.1.2

    Patients

    Seq Age Sex Outcome Treatment
    1