BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 4258814 · Received November 12, 2014

    Report

    Report Number
    2021710-2014-00067
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 14, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR IS CURRENTLY BEING EVALUATED BY A CAREFUSION FAILURE ANALYSIS TECHNICIAN. A FOLLOW UP REPORT WILL BE SUBMITTED TO THE FDA WHEN THE DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN WHILE IN PATIENT USE AND FAILED TO ALARM. THE PATIENT WAS THEN MANUALLY VENTILATED WITH AN AMBU BAG AND WAS PLACED ON ANOTHER VENTILATOR. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM AND THAT THE PATIENT'S VITAL SIGNS REMAINED STABLE THROUGHOUT THE EVENT. VENTILATOR SETTING (ADULT): MODE - VOLUME AC. BREATH RATE - 12. PEAK FLOW - 60. PEEP - 5. FIO2 - 100%. VOLUME - 0.7L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727964 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention