BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT

    MDR report key: 1021576 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06317
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 23, 2008
    Report Date
    March 5, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, DR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE TUBING DETACHED AT THE VAMP RESERVOIR. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT FLOTRAC SENSOR WITH VAMP SYSTEM DYG EDWARDS LIFESCIENCES, DR MHD6AZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other