BEUDAMED
    FDA Recall Terminated

    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    Recall: Z-1898-2016 · Initiated May 17, 2016

    Recall

    Recall Number
    Z-1898-2016
    Event Number
    74111
    Firm
    Carefusion 211 Inc dba Carefusion
    FEI Number
    3013421741
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 17, 2016
    Posted
    June 13, 2016
    Terminated
    September 28, 2017
    Address
    22745 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4668

    Description

    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    Reason

    CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

    Action

    CareFusion sent a Field Safety Notice dated May 17, 2016, to all affected customers. The notice informed customers that CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). This malfunction creates a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation to the patient. By design an audible clinical alarm is activated. Customers were informed of the problems identified and the actions to be taken. Customers were not required to return the affected devices or suspend use, customers would receive an copy of the identified affected serial numbers, as well as a response card, customers were requested to promptly return the response card to expedite the correction process and acknowledge receipt of the notification, Customers would be contacted by CareFusion to arrange onsite remediation of the affected devices, in the interim if any AVEA ventilator unit in their facility exhibits a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support per the contact information listed below to report the issue. Customers with questions should call 888-562-6016, for technical support 800-231-2466 or [email protected].

    Distribution

    Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

    Quantity

    922 units total (501 units in US)