BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3955767 · Received July 24, 2014

    Report

    Report Number
    2031702-2014-00176
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN INADVERTENTLY ACTIVATED THE SBT MODE ON THE VENTILATOR WHILE ATTEMPTING TO GIVE MANUAL BREATHS TO A PEDIATRIC PATIENT. AS A RESULT, THE PATIENT DECOMPENSATED QUICKLY AND INTERVENTION WAS PROVIDED TO IMPROVE VENTILATION. THE CLINICIAN WAS ABLE TO END THE SBT MODE AND RETURN THE VENTILATOR TO NORMAL VENTILATION. NO LONG TERM PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434907 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R