Events

Recall of AVEA 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
    70920
  • Event Risk Class
    Class 1
  • Event Number
    Z-1609-2015
  • Event Initiated Date
    2015-04-03
  • Event Date Posted
    2015-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135529
  • 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
    A pressure transducer failure can develop, activating a false extended high ppeak or circuit occlusion alarm. the safety valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. the malfunction may delay initiation or cease ventilation. nonbreathing patients will need manual ventilation or to be connected to another ventilator.
  • Action
    A customer letter dated 4/21/15 will be sent to all customers who received the AVEA Ventilator, all models, to inform them that CareFusion has identified a potential risk associated with AVEA Ventilator caused by a malfunction of a pressure transducer. The malfunctioning pressure transducer is detected and by design ceases ventilation and opens the safety valve to atmosphere allowing spontaneous breathing of patients capable of doing so. The non-breathing patient would need to be manually ventilated. The letter informs the customers of the issues, the potential risk, and the actions to be taken. Customers are instructed to contact CareFusion Recall Support Center at (888) 562-6018, (858) 617-5300, or email supportcenter@carefusion.com for recall related questions. Customers are instructed to contact CareFusion Technical Support/Customer Advocacy at (800) 231-2466, (714) 283-2228, or email support.vent.us@carefusion.com for Product Technical Support Adverse Event Reporting. CareFusion posted a press release on their website on 5/27/15 and it was sent to PRNewswire. The press release provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators. The press release provide the problems and the actions to be taken. The press also list the countries that are affected by the recall.

Device

AVEA ventilator
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvadore, Estonia, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Rep), Kuwait, Latvia, Lebanon, Libyan Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, Nicaragua, Norway, Occupied Palestinian Territory, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, South Africa, South America, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
  • Product Description
    CareFusion AVEA ventilator, all models. || Product Usage: || A continuous ventilator (respirator), intended to mechanically control or assist 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