| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00762-1 |
| Product Name/Description |
Astral 100 and 150 ventilators
All Astral External Batteries
All Astral Battery Packs
ARTG Numbers: 219429 and 158756 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
ResMed has received a number of reports about the performance of the internal battery, where false activation of a fuse leads to shut down of the internal battery. Prior to the issue occurring, one or more of the following alarms were activated: Battery inoperable, Power fault / No charging, Device overheating. If the device is running on external power then ventilation will continue. If the device is not running on external power, or external power is removed, then ventilation will stop with activation of the total power fail alarm. Reconnection to external power will enable ventilation to recommence.
When ventilators use the internal battery as the sole power source, any performance issue with the battery could lead to cessation of therapy. In these cases, ventilator-dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation.
There have been no reports of this issue in Australia to date, nor any adverse health effects. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ResMed is providing a Clinical Guide addendum that is to be kept with existing Clinical Guides that includes the following warning:
The internal battery is NOT intended to serve as a primary power source. It should only be used briefly when necessary; for example, when changing power sources, or when other sources are temporarily unavailable.
In addition, users and carers are to continue to follow all patient and device information in the Astral User and Clinical Guides, in particular the following warnings:
- For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in patient injury or death.
- Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1300 305 705 - ResMed Customer Service |