BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1881681 · Received October 1, 2010

    Report

    Report Number
    1881681
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 1, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SVO2 CATHETER BENT UPON ATTEMPTING TO INSERT - UNABLE TO USE. NO PROBLEM INSERTING SECOND CATHETER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CENTRAL VENOUS CATHETER OXIMETRY KIT DQE EDWARDS LIFESCIENCES X3820HKCDC 58595052

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES