BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 2142261 · Received June 22, 2011

    Report

    Report Number
    2142261
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 22, 2011
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. ON AVEA VENTILATOR FOR TWO DAYS WHEN MACHINE STARTED TO ALARM INVALID GAS ID. VENTILATOR WAS PULLED OUT OF SERVICE AND PATIENT PLACED ON A DIFFERENT VENTILATOR AT THE SAME SETTINGS. PATIENT EXPERIENCED NO ADVERSE EFFECTS. UPON TROUBLESHOOTING VENTILATOR, AS PER MANUAL, WE FOUND THAT THE CORRECT CONNNECTORS WERE IN USE AND THE LINES WERE TIGHT.====================== MANUFACTURER RESPONSE FOR VENTILATOR, VIASYS (PER SITE REPORTER)======================ITEM WAS TAKEN TO BIOMED AND SERVICE CALL WAS MADE TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 207, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR