CareFusion Avea ventilators recalled because of risk of death or serious injury
A Class 1 recall has been issued for the CareFusion Avea ventilators. Class 1 recalls are the most serious recalls issued by the Food and Drug Administration, meaning that the defects may result in serious injuries or death. The recall for the ventilators is due to a defective fuse on the alarm board of the devices, which might lead to unexpected shutdowns. When a ventilator shuts down, the patient might not receive sufficient oxygen.
Avea ventilators are used in health care facilities and hospitals to provide continuous respiratory support for adults, children and infants. CareFusion issued an alert to healthcare facilities about the dangers that could happen when using the Avea ventilators. The instructions, which were issued in May 2016, directed health-care facilities to stop using the devices and to remove them. The recall includes 501 ventilators that were distributed between Nov. 2015 to Feb. 2016.
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Patients are at risk because of the electrical defect
CareFusion sent a safety notice indicating that an F1 fuse located on the alarm boards might either blow or fail, making the units lose power. Because these units are used to help infants, children and adults suffering from breathing problems to receive the oxygen they need, their failure can potentially harm patients of all age groups. A defective medical device lawyer in Reno, Nevada, may review the medical documentation in order to determine if an injury or death was caused by a faulty CareFusion Avea ventilator.
CareFusion’s problematic history
CareFusion has issued numerous ventilator recalls over the years. Twenty-two Class 1 recalls of the company’s continuous ventilators have been issued since 2011 with six being recalled directly by the company. The company issued a worldwide recall in 2015 for thousands of ventilators that had defective pressure transducers. With that recall, the ventilators activated false alarms and then stopped ventilating. A total of 15,905 Avea ventilators that were manufactured between July 1, 2011, to March 15, 2015, were affected.
Those who have the highest risk
Any patient who uses the recalled Avea ventilator systems is at risk. These are often used to provide breathing support while people are undergoing surgery, when they have received anesthesia or if they have impaired lung functioning due to disease. Ventilators might be used for hours or days during and following surgeries. People who have conditions that cause poor lung functioning may have to use ventilators on a long-term basis.
Ventilators may be needed for people who suffer from any of the following conditions:
- Chronic obstructive pulmonary disease
- Amyotrophic lateral sclerosis
- Traumatic brain injuries and strokes
- Lung diseases
The recalled CareFusion Avea ventilators
Several ventilator models have been included in the latest recall. These include the Avea comprehensive, standard, standard with compressor, TCA board and GDE ventilators. Both first generation and models that have been refurbished are subject to the recall.
Duty of care
Medical device manufacturers such as CareFusion have a duty to provide defect-free, safe equipment to hospitals for patients. Unfortunately, the company has a history of providing products that are defective, resulting in patient harm. The company settled a lawsuit in 2014 for more than $40 million in a case alleging that CareFusion misrepresented their products and paid out kickbacks. The company’s continued issues and problematic history has led to defective medical device lawyers in Reno, Nevada, to work to hold CareFusion accountable for releasing defective products in the market.
What patients can do when they require ventilation
If a person has a disease or a surgery that will require ventilation, he or she may want to ask the healthcare facility what ventilator will be used. He or she might want to check the Food and Drug Administration’s recall notice to make certain that the hospital is not using one of the specific models that are subject to the recall. If the ventilator is one that has been recalled, the person might want to alert his or her healthcare provider about the recall. This can help to prevent injuries that might occur both to the patient as well as to others who may later also require ventilation either temporarily for surgery or on an ongoing basis.
Class 1 recalls are the most serious types of recalls, and they are reserved for medical products that can kill or seriously injure patients. It is important for patients and healthcare facilities alike to be aware of the CareFusion Avea ventilator recalls so that they can take steps to prevent the injuries and deaths that could otherwise occur. Asking questions about the care that will be received and the equipment that will be used may help patients to determine whether or not the ventilators that will be used are ones that have been recalled.