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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00467-1
Product Name/Description Newport HT70 and HT70 Plus Ventilators

ARTG Number: 14214
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/04/2017
Responsible Entity Covidien Pty Ltd
Reason/Issue Medtronic have received reports that Newport HT70 and Newport HT70 Plus ventilators 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. The reported incidence of the reset without alarm condition is approximately one (1) reset in every 7 million hours of ventilation. While the reports indicated that patients required transfer to another ventilator, no patient injury or impairment has been reported. There have been no reports of adverse events in Australia.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic will provide a software update to resolve the issue, with expected availability end of May 2017. In the interim, an alternative ventilator should be used for patients who are ventilator dependent and have severe lung injury, and all other users should access alternative ventilators where possible and until the corrective actions can be implemented. If the Newport HT70 or Newport HT70 Plus ventilators are to be used, users are to ensure patients on ventilators are appropriately monitored by trained caregivers as described in Operator’s Manual and as detailed in the customer letter.

This action has been closed out on 26/07/2019
Contact Information 1800 350 702 - Medtronic Technical Services Department