BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCO CATHETER INTERFACE CABLE

    MDR report key: 1000586 · Received February 18, 2008

    Report

    Report Number
    6000002-2008-06078
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, BLOOD TEMP INCORRECT/UNSTABLE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCO CATHETER INTERFACE CABLE CCO CABLE DYG EDWARDS LIFESCIENCES 70CC2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK