BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO-SET

    MDR report key: 679829 · Received January 9, 2006

    Report

    Report Number
    679829
    Event Type
    Malfunction
    Date Received
    January 9, 2006
    Date of Event
    January 4, 2006
    Report Date
    January 9, 2006
    Manufacturer
    EDWARD LIFESCIENCES, LLC
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF WAS PREPARING TO DO A CARDIAC OUTPUT TEST. THE DEVICE WAS OPENED NEW, OUT OF THE BOX AND SET UP TO PRIME. STAFF REPORTS THAT THE TUBING WOULDN'T PRIME AND THAT THE SYRINGE WOULDN'T PULL THE FLUID THROUGH THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO-SET CARDIAC TUBING DRS EDWARD LIFESCIENCES, LLC * 58203518

    Patients

    Seq Age Sex Outcome Treatment
    1 *