| TGA Action ID |
RC-2026-RN-00425-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Astral 100 and Astral 150 Ventilators
Manufactured prior to October 2024
Astral 100 and Astral 150 ventilators with serial numbers below 22241890149 (Global)
Astral 100 and Astral 150 PCBA spare parts with serial numbers below 22241978070
Astral PCBA spare part: Characters 2–8 < 2707658 |
| ARTG Number |
219429 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
Resmed has identified that an internal electrical component (supercapacitor) in a subset of Astral 100 and Astral 150 ventilators may leak electrolyte over time. The leakage may damage circuitry on the printed circuit board assembly (PCBA), causing the ventilator to inadvertently enter a fail-safe state.
If this occurs while therapy is being delivered, therapy will stop and a high-priority audible alarm will activate. The ventilator will be unable to deliver therapy, requiring an alternative means of ventilation.
Based on Resmed's investigation, the occurrence rate of this problem is approximately 0.1%. |
| Instructions for Customers/Users |
Clinicians are to:
- Review patients using affected ventilators and assess individual patient risk, using clinical judgement and continuing therapy unless a suitable alternative is available and clinically appropriate.
- Provide patient risk information when arranging service or maintenance to support prioritisation under ResMed's phased correction program.
- Reinforce adherence to Astral guidance, including patient monitoring, ventilator alarm response training, and ensuring backup ventilation equipment is available, functional, and ready for immediate use.
Patients and carers are to:
- Ensure alternative ventilation equipment, such as a backup ventilator or manual resuscitator, is available, functional, and ready for immediate use.
- Ensure ventilator-dependent patients are appropriately monitored at all times.
- Maintain familiarity with ventilator alarms and emergency procedures, and be confident in responding to alarm conditions and interruptions to therapy.
ResMed will provide further information as it becomes available. |
| Action Commencement Date |
2/07/2026 |
| Responsible Entity |
|
| Contact Information |
astralresponse@resmed.com - Resmed |