BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 4950943 · Received July 29, 2015

    Report

    Report Number
    2031702-2015-00151
    Event Type
    Death
    Date Received
    July 29, 2015
    Date of Event
    May 20, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS. THE VENTILATOR PASSED THE LTV FINAL TEST WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS. A REVIEW OF THE EVENT TRACE REVEALED MULTIPLE ¿O2 LOW1¿ ALARM CONDITIONS DUE TO THE SUPPLIED O2 SOURCE BEING LESS THAN THE REQUIRED 35 PSI. THE EVENT TRACE DID NOT REVEAL ANY CONDITION THAT WOULD INDICATE THAT THE VENTILATOR ALARMED FOR ¿HIGH O2¿. ALL OTHER EVENT TRACE ENTRIES ARE CONSISTENT WITH NORMAL VENTILATOR OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LTV VENTILATOR WAS TURNED ON, IT STARTED ALARMING DISCONNECT AND WAS PLACED ON THE PATIENT. AS SOON AS THE LTV VENTILATOR WAS PLACED ON THE PATIENT, THE LTV HAD A HIGH O2 PRESSURE ALARM. THE PATIENT WAS VERY ILL AND WENT INTO CARDIAC ARREST AT THE PRECISE MOMENT THE LTV WAS CONNECTED TO THE AIRWAY (ETT). THE VENTILATOR WAS IMMEDIATELY REMOVED AND THE PATIENT WAS PLACED ON THE ANESTHESIA VENTILATOR. THE PATIENT PASSED AWAY DUE TO UNDERLYING MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492740 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Death