BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA DURA2

    MDR report key: 1113123 · Received August 1, 2008

    Report

    Report Number
    1113123
    Event Type
    Malfunction
    Date Received
    August 1, 2008
    Date of Event
    April 15, 2008
    Report Date
    July 28, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KGAA
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR SCREEN WENT BLANK, BUT DID NOT CAUSE ANY HARM TO PATIENT. THE VENTILATOR CONTINUED TO VENTILATE PATIENT. THE PATIENT'S VITAL SIGNS DID NOT CHANGE. VENTILATOR WAS REMOVED OUT OF SERVICE. VENTILATOR SCREENS WERE WORKING DURING VENTILATOR CHECK JUST THIRTY MINUTES PRIOR TO EVENT. THE COMPLAINT WAS VERIFIED IN BIOMED AND REPAIR COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA DURA2 VENTILATOR CBK DRAEGER MEDICAL AG & CO. KGAA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY