BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 4888829 · Received July 2, 2015

    Report

    Report Number
    2031702-2015-00123
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    December 3, 2013
    Report Date
    July 2, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS HOLDING THE VENTILATOR IN QUARANTINE AND HAS NOT RETURNED IT TO THE MANUFACTURER FOR AN EVENT TRACE DOWNLOAD AND NON-INVASIVE TESTING. THIS REPORT IS BEING FILED BEYOND THE 30 DAY MDR FILING TIME-FRAME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN OFF OF HER PRIMARY VENTILATOR AND PUT ON THE BACK-UP VENTILATOR TO TAKE A BATH. IT IS UNKNOWN WHAT OCCURRED TO CAUSE THE PATIENT DEATH. IT IS ALSO UNKNOWN IF THE VENTILATOR WAS CONNECTED TO THE PATIENT WHEN SHE PASSED AWAY. AT THIS TIME, THERE ARE NO ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432831 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1 Death