CareFusion is recalling its AVEA ventilators because of a faulty fuse on the device’s alarm board, which may cause the ventilator to unexpectedly shut down. When ventilators shut down, patients may not receive enough oxygen, and may cause serious health consequences, including death.
In May, 2016, CareFusion alerted health care facilities of the potential deadly dangers of using these devices. The company instructed health care professionals and consumers to cease using and remove the ventilators from their facilities.
The company says they are recalling over 500 units, manufactured and distributed from November, 2015 to February, 2016. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, which indicates the use of these devices may cause serious injuries or death.
Joe Lyon has represented hundreds of individuals harmed by faulty medical device products nationwide. For questions related to the CareFusion AVEA lawsuit call for a no cost consultation (800) 513-2403.
In a safety notice, CareFusion cited an electrical issue that “caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power.” The company urges health care officials to “immediately remove the ventilator from service.”
The AVEA ventilator is intended for continuous breathing support for infants, children and adults. Modern ventilators, sometimes called “respirators,” are computerized machines, used in hospitals, home care, and emergency medicine. The machines are designed to move air into and out of the lungs, to provide breathing for patients physically unable to breathe.
If the company’s products do not function as advertised, victims of the failing machines may have a claim against the negligent manufacturer.
Unfortunately, this is not the first CareFusion ventilator recall, and there is evidence that the company has failed to provide safe products in the past. In fact, since 2011 there have been 22 Class 1 recalls of continuous ventilators like the AVEA, including six device recalls by CareFusion.
In 2015, CareFusion recalled thousands of AVEA ventilators worldwide in response to a malfunctioning pressure transducer. The affected AVEA ventilators developed a failure mode over a period of time, where the ventilator activated false audio and visual alarms, and stopped ventilating.
The safety alert notice said the malfunction affected the Avea’s main function, precisely “to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.”
This particular recall involved 15,905 AVEA ventilators manufactured and distributed from July 1, 2011 to March 15, 2015, including 5,670 affected units in the U.S.
The FDA classified it a very serious Class 1 recall, meaning the agency believes there is a reasonable chance that the use of the device “will cause serious adverse health consequences or death.”
All patient groups using these specific AVEA ventilator systems for breathing support may be affected. Ventilators most often are used during surgery, if anesthesia is administered, or if a disease or condition impairs lung function.
A ventilator helps ensure that patients continue breathing during surgery. Depending on the type of surgery, a ventilator may be used for a few hours or several days. For patients with an impaired lung function, and for those with difficulty breathing without assistance, long-term use of ventilators is not uncommon.
The most common conditions and factors that affect lung function, and may necessitate using a ventilator include:
• Chronic obstructive pulmonary disease
• Upper spinal cord injuries
• Amyotrophic lateral sclerosis (ALS)
• Myasthenia gravis
• Brain injury or stroke
• Drug overdose
• Other lung diseases
The following device models are included in CareFusion’s most recent recall:
• AVEA Comprehensive ventilator (and refurbished model)
• AVEA Standard ventilator (and refurbished model)
• AVEA Standard with Compressor ventilator (and refurbished model)
• TCA Board
• GDE (1st Generation and refurbished models)
CareFusion, and other manufacturers of medical devices used in America’s healthcare facilities, have a responsibility to provide consumers and vulnerable patients with proven, safe equipment. However, companies like CareFusion have continually shown a disregard for consumer safety in favor of company profit.
In 2014, CareFusion settled a lawsuit for over $40 million, which alleged the company was involved in paying kickbacks to doctors, and misrepresenting their products. In light of other recent issues, such as malfunctioning devices like the AVEA ventilator, victims and experienced attorneys are holding the company accountable for its actions. Anyone affected by CareFusion’s faulty devices may have a claim against the company, and can contact a lawyer to help assess the legal options available.
If you or a loved one suffered an injury due to a faulty ventilator and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions