CareFusion has recalled the AVEA Ventilator, which the FDA has identified as a Class I recall. This is the most serious class of recalls because using the device can result in serious injury or even death. Several components have been recalled related to this product:
- Refurbished AVEA standard with compressor ventilator
- AVEA comprehensive ventilator
- AVEA standard ventilator
- AVEA standard ventilator with compressor
- Refurbished AVEA comprehensive ventilator
- Refurbished AVEA standard ventilator
- Refurbished AVEA standard ventilator with compressor
- TCA board
- 1st generation GDE
- GDE
- Refurbished GDE
- AVEA GDE/UIM upgrade kit
The manufacturing dates for these items was November 13, 2015 to January 4, 2016. They were distributed between December 16, 2015 and February 15, 2016. A total of 501 units distributed throughout the U.S. have been recalled.
Why Was The CareFusion AVEA Ventilator Recalled?
The reason for the recall is because a faulty fuse has been located on the ventilator’s alarm board. The ventilator may shut down unexpectedly, which may cause the patient not to be able to receive the oxygen he needs to breathe. The result can cause major health issues, including death. The device is used on people of all ages, including children, to provide continuous breathing support. It is used in hospitals and other medical facilities. Any health care provider that uses the AVEA ventilator will be impacted by this recall, as well as patients who are using the device for assistance with breathing.
Guidelines from the FDA require the companies to take full responsibility for the recalls. They must follow up to ensure all recalls were completed successfully. They are required to notify the FDA when the recall began and provide updates until it has been finished.
CareFusion issued a notice to medical facilities on May 17, 2016 with instructions on how to respond to the recall. They were given an acknowledgement and receipt form they must complete and return. Once the company receives the form, it should schedule an on-site remediation at the facility for all affected devices. The health care facility and consumers are directed to report any adverse event or problems with the quality of the device to the FDA either by calling 1-800-FDA-1088 or through MedWatch Online.
If you have questions, contact CareFusion at supportcenter@carefusion.com or call 888-526-6018.
What Should I Do If I Have Been Injured By A Medical Device?
If you or a family member has been injured because of a malfunctioning AVEA respirator, contact an attorney to discuss if you have a legal claim for compensation for your injury. An attorney can assess the situation and offer legal counsel to help you determine the next steps you should take regarding your defective medical device claim. When a device malfunctions because of faulty design or a manufacturing flaw, the victim is entitled to seek recompense for their injury.
The Olinde Firm represents clients nationwide who have been injured by a defective medical device. You only have a limited time to file a defective medical device claim. Contact our office at (504) 587-1440 or 1-800-587-1889 to schedule a free legal consultation. We accept defective medical device claims on a contingency basis — you don’t pay our attorney fees until you receive compensation for your injuries.