Medtronic Newport Ventilator Warning Indicates Devices May Unexpected Reset During Use
Federal health officials have announced a field corrective action for certain Medtronic ventilators, due to a risk that the devices may unexpectedly reset during operation, posing a risk of serious and potentially fatal adverse health consequences in emergency situations.
A Medtronic Newport HT70 Plus Ventilator warning was issued by the FDA on April 5, following at least a dozen reports of problems where the ventilator machines spontaneously reset during use, delaying patient ventilation treatment.
To date, no injury or impairment incidents have been reported in connection with the devices. Of the 12 incident reports, 11 involved patients that had to be transferred to another machine after the ventilator sporadically reset. One incident did not involve a patient.
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Although the ventilator field corrective action has not yet been classified as a Medtronic Newport Ht70 Plus ventilator recall by the FDA, patients who suffer from serious respiratory issues and require ventilation treatment may be at an increased risk of injury in the event the machines reset.
The HT70 Plus Ventilators provide breathing support in emergency or routine situations. They are used in clinical or in-home settings for infant, pediatric and adult patients with respiratory complications.
According to the FDA, the ventilators may reset without any alarm or warning during normal operation. Following the reset, the ventilators may enter a standby mode that will not resume ventilation without intervention. Patients should be transferred immediately to a backup ventilation source to prevent delay or omission of respiratory treatment.
The field corrective action involves an estimated 14,000 Medtronic Newport HT70 and HT70 Plus ventilators that were sold internationally since August 2012.
The FDA is asking customers to follow several recommendations until the devices can be updated, which include monitoring patients on ventilators at all time and to always have an alternative means of respiratory ventilation.
Medtronic indicates that the company has established the root cause of the defect and has a plan to remedy the devices by providing a software update. The software update is expected to be available for updating devices in May 2017. Customers with questions regarding the ventilator issues may contact Medtronic Technical Support Department at 1-800-255-6774.
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