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Spontaneous Ventilator Reset; Voluntary Corrective Action


On April 5, 2017, Medtronic notified customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator.

 

A Newport HT70 ventilator is used to support a patient’s breathing. This prescription device is operated by trained healthcare professionals in a clinical setting and in the home for infant, pediatric, and adult patients.

 

Since August 2012, and of the more than 14,000 ventilators in use, Medtronic has received 12 reports of the reset without an accompanying alarm. Of these 12 reports, 11 patients required ventilator transfer and one incident did not involve a patient. No patient injury or impairment has been reported. The reported incidence of this condition is approximately one reset in every seven million hours of ventilation.

 

Medtronic has established the root cause of this alarm failure and will provide a software service update to resolve the issue as soon as the correction can be implemented. The service update is expected to be available May 2017.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe

 

 

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