FDA: Field corrective action for Medtronic’s Newport HT70, HT70 Plus ventilators

Editor's Note

On April 5, the Food and Drug Administration (FDA) announced that Medtronic (Minneapolis) has notified its customers of a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010.

The field corrective action is being conducted after 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.

Since August 2012, Medtronic has received 12 reports of the reset without an accompanying alarm. Medtronic has found the cause of the alarm failure and will provide a software service update.  The service update is expected to be available May 2017.

Posted 04/05/2017] AUDIENCE: Risk Manager, Pulmonology, Nursing ISSUE: 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.