BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC

    MDR report key: 4920984 · Received July 10, 2015

    Report

    Report Number
    4920984
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 6, 2015
    Report Date
    July 10, 2015
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF MEMBER WAS SETTING UP FLOTRAC. STAFF MEMBER STATED THAT WHEN THEY WENT TO CHECK ASSEMBLY, LUER CONNECTOR BROKE AT THE TRANSDUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450944 FLOTRAC EDWARDS LIFE SCIENCE FLO TRAC DRS EDWARDS LIFESCIENCES LLC MHD8 59924459

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR