Metropolitan Boston Emergency Medical Service Council

25 B Street, Suite A Burlington, Massachusetts 01803

781-505-4367 (voice) | 781-272-6967 (fax)

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04/06/17

FDA MedWatch Alert RE: Newport HT70 and HT70 Plus Ventilators by Medtronic: Voluntary Field Corrective Action

Office of Emergency Medical Services

DEPARTMENT OF PUBLIC HEALTH                                                                                                               

COMMONWEALTH OF MASSACHUSETTS

 

Notice

FDA MedWatch Alert: Newport HT70 and HT70 Plus Ventilators by Medtronic: Voluntary Field Corrective Action - Ventilator May Reset Spontaneously

Please see the U.S. Food and Drug Administration (FDA) website, athttps://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm551021.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery, for MedWatch information regarding Medtronic’s voluntary field corrective action with respect to 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. Since August 2012, 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 (1) incident did not involve a patient. No patient injury or impairment has been reported. The reported incidence of this condition is approximately one (1) 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.

 

Ambulance services with these ventilators are advised to read the MedWatch safety alert for more information and recommendations set out in that document.