BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 6201440 · Received December 22, 2016

    Report

    Report Number
    2021710-2016-05084
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 24, 2016
    Report Date
    December 22, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. THE USER FACILITY IS CONDUCTING FURTHER INVESTIGATIONS TO THE POSSIBLE SOURCES OF THE INFECTIONS. THERE IS NO FURTHER INFORMATION PROVIDED AT THIS TIME AND NO RETURN OF PRODUCTS ARE EXPECTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A GENERAL CONCERN ACROSS THEIR HOSPITAL THAT VENTILATORS WERE POTENTIALLY CAUSING INFECTIONS IN PATIENTS. THE CUSTOMER REPORTED THAT IT WAS NOT ONLY WITH CAREFUSION VENTILATORS BUT ALSO VENTILATORS FROM OTHER MANUFACTURERS. THE CUSTOMER HAS BEEN CHECKING POSSIBLE SYSTEMIC SOURCES OF INFECTION, SUCH AS SUCTIONING CHANNELS, HVAC, AND NON HYGIENIC PRACTICES, BUT HAS NOT FOUND A SOURCE YET. THE CUSTOMER'S INFECTION CONTROL DEPARTMENT IS SUSPECTING THE VENTILATORS AS WELL AS OTHER SOURCES. THERE WAS NO INFORMATION OR DETAILS ON THE INFECTIONS OR CONDITIONS OF THE PATIENTS AND AT THIS TIME THERE IS NO KNOWN ISSUE DIRECTLY RELATED TO THE PERFORMANCE OF THE VENTILATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851482 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L