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

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

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

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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

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. 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 Aug. 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 (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.

BACKGROUND: 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.

RECOMMENDATION: Medtronic is advising that you may continue to use your Newport HT70 series ventilators in accordance with institutional policies and as described below. Actions you should take:

• Ensure patients on the Newport HT70 and HT70 Plus ventilators are appropriately monitored by trained caregivers as described in the Operator’s Manual. The descriptions include:
  • A patient connected to a ventilator requires the constant attention of trained caregivers to the patient’s condition.
  • Always have an alternate power source and means of ventilation available when the ventilator is in use in case of a mechanical or system problem.
  • Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as a pulse oximeter and/or a capnograph) when the Newport HT70 or HT70 Plus ventilators are in use on a patient.
  • If able, use the appropriate remote alarm/nurse call cable (CBL3223 or 10104494) to project ventilator alarm states outside the patient room. This alarm will annunciate even with an unexpected reset. Consult the Operator’s Manual or call Technical Service for further information on this accessory.
  • If, at any time, the patient is not responding to ventilation appropriately, the patient should be taken off the ventilator immediately and connected to an alternate method of ventilation. Contact your health care provider or physician immediately.
• Immediately notify all care environments in which the Newport HT70 and HT70 Plus ventilators are used about this notification.
• If your facility has distributed Newport HT70 or HT70 Plus ventilators to other persons or facilities, please promptly forward this announcement to those recipients.
• Work with Medtronic Technical Support Department if you require assistance finding alternative ventilation devices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm551021.htm

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