BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI Q SVO2/CCO CATHETER

    MDR report key: 1910764 · Received November 29, 2010

    Report

    Report Number
    1910764
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    August 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COULD NOT CALIBRATE====================== HEALTH PROFESSIONAL'S IMPRESSION======================SAME AS ABOVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI Q SVO2/CCO CATHETER OPTI Q SVO2/CCO CATHETER DQE HOSPIRA, INC. LIST NO. 52511-13 88-103-2A

    Patients

    Seq Age Sex Outcome Treatment
    1 *
    2