BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE II CCO MONITOR

    MDR report key: 4192347 · Received October 7, 2014

    Report

    Report Number
    4192347
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT 0600, NURSE NOTICED CARDIAC INDEX BEGAN TO DECLINE. AFTER CHECKING MONITORING SYSTEM TO ENSURE ALL CONNECTIONS WERE OKAY AND NO ERRORS ON THE SCREEN WERE PRESENT, THE MONITOR SCREEN SUDDENLY TURNED BLUE WITH AN ERROR CODE AND SHUT OFF. THE MONITOR AND CABLES WERE IMMEDIATELY REPLACED AND THE MONITOR TAGGED. ANOTHER DEVICE WAS OBTAINED AND PATIENT MONITORING CONTINUED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630094 VIGILANCE II CCO MONITOR COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES LLC VG005909 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR