BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 1013000 · Received March 4, 2008

    Report

    Report Number
    1013000
    Event Type
    Malfunction
    Date Received
    March 4, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 4, 2008
    Manufacturer
    VIASYS HEALTHCARE MEDSYSTEMS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR HAD A TOUCH SCREEN THAT APPEARED TO BE FROZEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR CBK VIASYS HEALTHCARE MEDSYSTEMS AVEA *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR