BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY SENSOR

    MDR report key: 1122171 · Received August 14, 2008

    Report

    Report Number
    6000002-2008-08427
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCE, DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE VIGILEO MONITOR SHOWED WRONG VALUES WITH THE USE OF THE FLOTRAC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY SENSOR FLOTRAC SENSOR DRS EDWARDS LIFESCIENCE, DR MHD6 58482307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other