BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 4259044 · Received November 12, 2014

    Report

    Report Number
    2021710-2014-00068
    Event Type
    Death
    Date Received
    November 12, 2014
    Report Date
    October 14, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION HAS REQUESTED FURTHER INFO FROM THE BUSINESS PARTNER IN (B)(4) REGARDING THE REPORTED PT EVENT. CAREFUSION HAS ALSO REQUESTED INFO FROM THE BUSINESS PARTNER REGARDING PERFORMANCE EVAL OF THE VENTILATOR DEVICE AS A RESULT OF THIS REPORTED EVENT. AS OF THIS REPORT THE BUSINESS PARTNER HAS NOT PROVIDED ADD'L INFO. A FOLLOW UP REPORT WILL BE SUBMITTED TO THE FDA IF FURTHER INFO IS RECEIVED FOR THE REPORTED PT EVENT AND DEVICE.

    Description of Event or Problem · 1

    CAREFUSION'S BUSINESS PARTNER REPORTED THAT THE THERAPIST AT THE HOSPITAL (B)(6) REPORTED THAT THE VENTILATOR WAS ALARMING "NOT VENTILATING" WHILE ON A PT AND THAT THE PT DIED. MODE OF VENTILATION = PRVC A/C. BREATH RATE: 16. TIDAL VOLUME: 0.60. INSP. PRESSURE: 1.10. PEEP/CPAP: 10. SENSITIVITY/FLOW TRIGGER: 3.0. FIO2: 90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729839 CAREFUSION VENTILATOR CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death NI/NI