BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA XL VENTILATOR

    MDR report key: 2181281 · Received July 21, 2011

    Report

    Report Number
    MW5021488
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DRAEGER MEDICAL INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRAGER EVITA XL VENT FAILURE: VENTILATOR WAS RUN THROUGH SYS CHECK PRIOR TO PLACING ON PT. CHECK PASSED, PLACED ON PT. THE VENT WENT INTO APNEA VENTILATION AND WOULD NOT VENTILATE PT. ALSO WOULD NOT ALLOW THERAPIST TO RESET IT OR CHANGE SETTINGS. PT REMOVED FROM VENT AND MANUALLY VENTILATED BY PHYSICIAN TO 100% OXYGENATION. VENT REMOVED FROM SVC AND SENT TO BIOMED DEPT. NEW VENT APPLIED AND PT VENTILATED WITHOUT ISSUE. VENTILATOR WAS FOUND TO HAVE A PNEUMATIC SYS FAILURE ON THE INTERNAL PANEL AND NEEDED A NEW FLOW SENSOR CABLE. DATES OF USE: (B)(6) 2006 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: POST OPEN HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA XL VENTILATOR VENTILATOR CBK DRAEGER MEDICAL INC EVITA XL SW6.N

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability