BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 3924431 · Received July 9, 2014

    Report

    Report Number
    2031702-2014-00172
    Event Type
    Death
    Date Received
    July 9, 2014
    Date of Event
    May 22, 2014
    Report Date
    December 29, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE PATIENT¿S MOTHER STATED THAT SHE HAD FORGOTTEN TO PLUG THE VENTILATOR IN WHEN SHE PUT THE PATIENT TO BED. IN THE MORNING, THE PATIENT¿S MOTHER HAD FOUND THE VENTILATOR WAS OFF, UNPLUGGED, AND THERE WAS NO AUDIBLE ALARM. THE PATIENT HAD PASSED AWAY. THE PATIENT HAD A PULSE OXIMETER AND HAD OXYGEN THAT COULD BE USED WITH THE VENTILATOR BUT THEY WERE NOT CONNECTED TO THE PATIENT WHEN THE EVENT OCCURRED. THE PATIENT WAS BEING TREATED FOR AN UPPER AIRWAY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401965 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death