BEUDAMED
    FDA Adverse Event Summary report: N

    AVEA

    MDR report key: 3042228 · Received April 2, 2013

    Report

    Report Number
    3042228
    Date Received
    April 2, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR NOT DELIVERING APPROPRIATE VOLUMES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134877 AVEA VENTILATOR CBK CAREFUSION 17310-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *