BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3143307 · Received May 23, 2013

    Report

    Report Number
    2031702-2013-00116
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS PLACED ON A PATIENT WITH SEVERE HEAD AND CHEST TRAUMA REQUIRING CLOSELY MONITORED END TIDAL CO2. THE VENTILATOR BEGAN AUTOCYCLING WITH AN AUDIBLE ALARM FROM THE SET BREATH RATE OF 10 TO A RATE OF 35-40 BREATHS PER MINUTE. THE FLIGHT NURSE ADJUSTED THE VENTILATOR SENSITIVITY BUT IT CONTINUED TO AUTOCYCLE. THE ET TUBE CUFF WAS INFLATED. THE PATIENT WAS REMOVED FROM THE VENTILATOR WHEN THE END TIDAL CO2 BEGAN TO DEGRADE. THE PATIENT WAS MANUALLY VENTILATED WITH NO FURTHER ISSUE. THE VENTILATOR WAS TESTED ON A TEST LUNG AFTER THE REPORTED EVENT AND THEY WERE UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228671 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention NI / NI