BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 6032534 · Received October 16, 2016

    Report

    Report Number
    2183926-2016-00768
    Event Type
    Malfunction
    Date Received
    October 16, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K051649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION BY THE SUPPORT DEPARTMENT DETERMINED THAT THE CUSTOMER ENTERED AN INCORRECT MEDICAL RECORD NUMBER WHEN INPUTTING PATIENT DATA, WHICH ALLOWED THE HEMODYNAMIC DATA TO MERGE WITH THE INCORRECT PATIENT RECORD. THE USER WAS INFORMED OF THE DATA ENTRY ERROR, AND REQUESTED THAT THE APPLICATION SETTINGS BE CHANGED TO MATCH ON ACCESSION NUMBER AND MRN TO FURTHER PREVENT ERRONEOUS MATCHING.

    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 REPORTED TO MERGE HEALTHCARE THAT HEMODYNAMIC DATA WAS INCORRECTLY IMPORTED TO THE WRONG PATIENT'S STUDY. INCORRECT DIAGNOSTIC DATA BEING IMPORTED TO A STUDY HAS THE POTENTIAL TO CAUSE INCORRECT TREATMENT OF THE PATIENT, WHICH COULD RESULT IN HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683814 MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS LLZ MERGE HEALTHCARE MERGE CARDIO V10.1.2

    Patients

    Seq Age Sex Outcome Treatment
    1