| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01074-1 |
| Product Name/Description |
Astral 100 and Astral150 Ventilators - Degraded Battery Pack
Serial Numbers below: 22161332346 for Astral ventilators, and 20160748193 for Astral external batteries
ARTG Numbers: 219429, 158756 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
ResMed has received a small number of reports regarding the performance of the internal battery in the Astral ventilator. In these reports, an internal electrical issue has led to ventilation ceasing without either the low battery alarm or the critically low battery alarm being activated. In all of these reported cases the “Total power failure” alarm activated as intended.
Under these circumstances, ventilator dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation. The risk of this occurring is increased if the internal battery has been charged a high number of times. This fault has also been reported with the Astral External Battery however, there have been no reports of cessation of ventilation when the Astral External Battery is used.
It remains safe to continue using Astral ventilators, provided patients/carers follow the precautions provided. There have been no reports of adverse health effects as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ResMed is providing users with work around instructions to follow as an interim measure. Patients and carers are advised to connect the ventilator to AC power whenever possible, and to use an external power supply where necessary. It is recommended that ventilator dependant patients have alternative ventilation equipment available at all times. All ventilators with an affected battery pack should have their internal batteries replaced by no later than 1 December 2016.
For further information, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators-0
This action has been closed-out on 23/03/2018. |
| Contact Information |
1300 305 705 - ResMed |