BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCO CATHETER INTERFACE CABLE

    MDR report key: 1070955 · Received July 3, 2008

    Report

    Report Number
    6000002-2008-07846
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADD'L SERIAL # (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, CONTINUOUS CARDIAC OUTPUT VALUES WERE INCORRECT. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK