BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE CARDIO

    MDR report key: 5749361 · Received June 24, 2016

    Report

    Report Number
    2183926-2016-00619
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    May 24, 2016
    Report Date
    May 24, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K051649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED MEASUREMENT MAPPING ISSUE WAS CORRECTED BY MERGE HEALTHCARE AND VALIDATED BY THE CUSTOMER.

    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 ALL PROXIMAL AORTIC ARCH MEASUREMENTS ARE BEING REPORTED AS DISTAL AORTIC ARCH MEASUREMENTS AND DISTAL AORTIC ARCH MEASUREMENTS ARE BEING REPORTED AS PROXIMAL AORTIC ARCH IN THE CLINICAL REPORTING TOOL. DUE TO AN INCORRECT VALUES DISPLAYING IN THE DIAGNOSTIC REPORT, THERE IS A POTENTIAL FOR INCORRECT TREATMENT OF A PATIENT THAT COULD RESULT IN HARM. THERE IS NO INDICATION THAT ANY PATIENTS HAVE BEEN HARMED AS A RESULT OF THIS MEASUREMENT MAPPING ISSUE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402295 MERGE CARDIO PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS LLZ MERGE HEALTHCARE MERGE CARDIO V10.1.2

    Patients

    Seq Age Sex Outcome Treatment
    1