BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 5086381 · Received September 17, 2015

    Report

    Report Number
    2031702-2015-00217
    Event Type
    Death
    Date Received
    September 17, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 17, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NON-INVASIVE TESTING WAS PERFORMED ON THE VENTILATOR. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS AND PASSED ALL ALARM TESTING. DURING THE LTV FINAL TEST, THE VENTILATOR HAD SLIGHT NON-CONFORMANCES WITH THE CALCULATED VTI AVERAGE TEST AND WITH THE BATTERY OPERATION TEST. THESE SLIGHT NON-CONFORMANCES WOULD NOT RESULT IN A FAILURE TO VENTILATE PROPERLY. THE EVENT TRACE WAS DOWNLOADED FOR REVIEW. IT CONTAINS CAPTURED EVENTS FROM (B)(6) 2015 THROUGH (B)(6) 2015. THE ALARM CODES FOUND IN THE EVENT TRACE ALL FALL INTO WHAT ARE CONSIDERED TO BE TYPICAL ALARMS THAT NORMALLY OCCUR DURING PATIENT VENTILATION. THE DATE OF THE REPORTED INCIDENT WAS (B)(6) 2015 AT APPROXIMATELY 3:25 PM. THE EVENT TRACE INDICATES THIS OPERATIONAL PERIOD STARTED ON (B)(6) 2015 AT 12:27 PM AND ENDED ON (B)(6) 2015 AT 03:24 PM. THE EVENT TRACE INDICATES THE VENTILATOR ISSUED A HIGH BREATH RATE ALARM CONDITION 10.6 MINUTES PRIOR TO BEING PROPERLY POWERED DOWN. THIS ENTRY HAS NO ASSOCIATED ALARM CLEAR ENTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. THE VENTILATOR WAS ALARMING AND THE NURSING STAFF FOUND THAT THE BACTERIA FILTER ON THE OUTLET PORT OF THE VENTILATOR HAD DISCONNECTED AND WAS HANGING DOWN WITH THE TUBING STILL ATTACHED. THE PATIENT WAS UNRESPONSIVE. THEY BEGAN MANUAL VENTILATION AND CALLED FOR ASSISTANCE. THE PATIENT WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615240 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Death