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FDA Announces Recall of Medtronic Newport Ventilators

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On April 5, 2017, the FDA announced a worldwide recall of about 14,000 Medtronic Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The manufacturer recalled these devices because of reports showing that the ventilator may reset during normal operation without an alarm warning. This can create a life-threatening situation for a patient relying on the ventilator to breathe.

Ventilators help people with respiratory problems breathe easier. They’re usually used during surgery while a patient is under general anesthesia, which decreases the patient’s ability to breathe on their own. Use of a ventilator ensures that patients can keep breathing throughout the procedure. Patients with serious lung disease or other conditions that affect normal breathing may also use a ventilator at home to assist with breathing.

Medtronic Recalls Ventilators Due to Software Issue

The FDA notes that ventilators are used by healthcare professionals in clinical settings and in the home for infants, children, and adult patients who are struggling with lung problems. Since 2012, Medtronic has received 12 reports of the recalled devices resetting out of the blue without an alarm sounding to warn that the ventilator had stopped working. After the ventilator is reset, it enters a standby mode and won’t work again without further intervention.

As the devices did not send a notification that the device had stopped working, the only way to figure out it had stopped working was by observing the patient’s symptoms. In 11 of the reported cases, healthcare professionals transferred the patients to another working ventilator. In the 12th case, the ventilator was not being used on a patient at the time it reset.

Medtronic says that it has identified why the alarm isn’t sounding and will provide a software update that should fix it. The update will not be available until May. It also advised healthcare professionals to continue using the devices, but to make sure that patients are monitored while the ventilator is in use and have an alternate ventilator available. If a patient is seen not responding to the ventilation, he or she should be transferred to another ventilator immediately.

Medtronic Has a History of Recalling Ventilators

This isn’t the first time Medtronic has had to recall their ventilators because of software issues. In July 2015, the company recalled about 600 of their Puritan Bennett 980 ventilator systems manufactured between March 2014 and June 2015. These ventilators were made by Covidien PLC, which Medtronic acquired in 2015. They provide constant breathing support for adults, children, and premature babies, and are most often used in hospitals.

Medtronic recalled these devices because of a software error that could cause a lower volume of air being delivered to the patient than the amount programmed in the machine by the healthcare professional. A patient failing to receive the full volume of air may not get enough oxygen, which may lead to injury and even death. At the time of the recall, the company advised practitioners to switch to another ventilator.