| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00744-1 |
| Product Name/Description |
Astral 100 and Astral 150 ventilators
Date of manufacture: Between 2013 and 2019
Reference numbers: 27083, 27081, 27003, 19600, 19653, 27082 and 27088
Multiple serial numbers
ARTG 219429
(Resmed Limited - Portable ventilator, electric) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2023 |
| Responsible Entity |
|
| Reason/Issue |
ResMed has identified an issue with the performance of the supercapacitor component of seven batches of the Astral 100 and 150 portable ventilators.
This component powers the TPF (total power failure) audible alarm which alerts the carer or clinician when the ventilator experiences a total loss of power that results in a stop of ventilation.
The problem with the component is that it degrades over time, which may cause the TPF alarm to sound for less than 2 minutes, or in some cases, to not sound at all.
This component does not affect any other alarm functionality, including low and critically low battery alarms.
This issue does not affect therapy delivery. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Phase 1:
Astral ventilators returned for service will undergo additional testing and repair (where needed) to address this issue.
Ventilators due for preventative maintenance (following the 2-year schedule) should be prioritised for return for maintenance. ResMed will provide replacement circuit boards for ventilators that are identified to be affected by this issue.
Users should ensure they follow the instructions for use, including:
- Connect the ventilator to the mains power whenever possible.
- For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device.
Phase 2:
ResMed are currently investigating long term solutions to prevent this issue occurring. It is anticipated an update will be provided by end 2023.
15/12/2023 update: ResMed will endeavour to communicate an update to customers on Phase 2 by Q1 2024 |
| Contact Information |
02 88841000 - ResMed Pty Ltd |