Avea Ventilator Case Study

Class I Recall from CareFusion for AVEA Ventilator
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. …show more content…
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