BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT

    MDR report key: 1011918 · Received March 10, 2008

    Report

    Report Number
    6000002-2008-06184
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, DR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION BETWEEN THE SENSOR AND THE LINE ON THE PATIENT'S SIDE BECAME BROKEN WHEN CUSTOMER WAS MAKING SURE THE CONNECTION WAS TIGHT ENOUGH. IT WAS FURTHER STATED THAT THE CUSTOMER DID NOT GIVE STRONG PRESSURE TO THE CONNECTION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT FLOTRAC SENSOR DYG EDWARDS LIFESCIENCES, DR MHD8S 58407907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other