BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 5069508 · Received September 10, 2015

    Report

    Report Number
    2031702-2015-00207
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 10, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    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, HAD SLIGHT NON-CONFORMANCES WITH THE PEEP PILOT PRESSURE TEST AND THE FLOW PERFORMANCE TESTS. THESE SLIGHT NON-CONFORMANCES WOULD NOT RESULT IN A FAILURE TO VENTILATE PROPERLY. PER THE CUSTOMER'S REQUEST, THE VENTILATOR WAS SENT BACK WITHOUT ANY REPAIRS BEING COMPLETED. THE EVENT TRACE WAS DOWNLOADED FOR REVIEW. THE DATE OF THE REPORTED INCIDENT WAS (B)(6) 2015 AT APPROXIMATELY 12:00 PM. THE EVENT TRACE INDICATES THIS OPERATIONAL PERIOD STARTED ON (B)(6) 2015 AT 11:39 PM AND ENDED ON (B)(6) 2015 AT 12:57 PM. THE EVENT TRACE INDICATES THE VENTILATOR ISSUED A LOW PRESSURE ALARM CONDITION 11 SECONDS 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'S HUSBAND FOUND THE PATIENT HAD PASSED AWAY WHILE ON THE VENTILATOR. THE PATIENT'S TRACH WAS PULLED OUT. THE PATIENT'S HUSBAND ADMITTED THAT HE CANNOT NORMALLY HEAR THE ALARMS AS HE WEARS TWO HEARING AIDS. THERE ARE NO ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING THE PATIENT HARM. IT WAS NOT NOTED IF THE VENTILATOR ALARMS WERE SEEN OR HEARD WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599547 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death