Medtronic Field Correction for Newport Ventilators

Medtronic has issued a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010 due to reports that the ventilator may reset spontaneously during normal operation, and without tripping an alarm. “The reported incidence of this condition is approximately one reset in every seven million hours of ventilation,” an FDA safety notice says. “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.”

Medtronic says it has received 12 reports of the reset without an accompanying alarm. The company says it has identified 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.