| Reason for the Action |
This is an update to the previously closed market action, TGA reference RC-2025-RN-00483-1.
Medtronic identified a limited subset of potentially affected goods for which the end consignee could not be determined due to the age of the products and limitations in historical distribution records. Out of an abundance of caution, all known HT70 consignees will be notified regarding these goods.
Investigation into customer complaints have identified two separate capacitors on one of the ventilator’s Printed Circuit Board Assemblies (PCBAs), that, in case of failure, may result in one of two distinct outcomes: The ventilator either shuts down during use, thus necessitating the use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down.
Cessation of operation and ventilation or loss of audible shutdown alarm in a mechanically ventilated patient may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, delay to treatment, or potentially severe consequences like brain injury and/or death.
Medtronic has identified 73 complaints and adverse health events associated with these problems, including one serious injury and two deaths. |