Events

Recall of Device Recall AVEA Standard with Compressor ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 211 Inc dba Carefusion.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74111
  • Event Risk Class
    Class 1
  • Event Number
    Z-1893-2016
  • Event Initiated Date
    2016-05-17
  • Event Date Posted
    2016-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146311
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • 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 support.vent.us@carefusion.com.

Device

Device Recall AVEA Standard with Compressor ventilator
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) || A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
  • Manufacturer
    Carefusion 211 Inc dba Carefusion

Manufacturer

Carefusion 211 Inc dba Carefusion
  • Manufacturer Address
    Carefusion 211 Inc dba Carefusion, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source
    USFDA