BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 6126696 · Received November 23, 2016

    Report

    Report Number
    2183926-2016-00800
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K051649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE ISSUE DETERMINED THAT THE MEASUREMENT WAS INCORRECTLY MAPPED AT THE TIME OF IMPLEMENATION. IT IS EXPECTED THAT THE CUSTOMER EVALUATES THE MEASUREMENTS TO CONFIRM THAT MEASUREMENTS ARE AS EXPECTED. MERGE HEALTHCARE SUPPORT CORRECTED THE MAPPING, AND CONFIRMED WITH THE FACILITY THAT THE CORRECT VALUE IS NOW IMPORTED. THIS CORRECTION RESOLVED THE CUSTOMER'S ISSUE.

    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 A DIAGNOSTIC MEASUREMENT TAKEN BY THEIR MODALITY WAS IMPORTING WITH THE INCORRECT UNIT OF MEASURE WITHIN THE CLINICAL REPORTING TOOL. 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. REFERENCE COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777100 MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS LLZ MERGE HEALTHCARE MERGE CARDIO V10.1.0

    Patients

    Seq Age Sex Outcome Treatment
    1