BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY SENSOR

    MDR report key: 1082675 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08132
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, BROKEN TUBING WAS OBSERVED WHEN THE PACKAGE WAS OPENED. FOLLOW UP INDICATED THAT THE TUBING WAS BROKE AT THE CONNECTION OF THE STOPCOCK SENSOR. 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 LIFESCIENCES, DR MHD8 58476474

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other