ResMed Limited — Astral 100 and Astral 150 ventilators

astral-100-and-astral-150-ventilators-0-1

What are the defects?

ResMed has received a number of reports regarding the performance of the internal battery in Astral 100 and Astral 150 ventilators. According to these reports, an internal electrical issue has led to ventilation stopping without either the 'low battery' or 'critically low battery' alarms activating as intended.

What are the hazards?

If ventilation stops without prior warning, 'ventilator-dependent' patients who are using the internal battery as the sole power source (for example, during mobile use or when AC power is unavailable or interrupted) may be at risk of serious health problems.

What should consumers do?

If you or someone you provide care for uses an Astral 100 or Astral 150 ventilator, be aware of this issue.

From September 2016, you should be contacted by your local service provider to schedule replacement of the internal battery. You can continue to use your ventilator in the meantime.

However, ResMed recommends that the following precautions be taken to minimise risks (especially for ventilator-dependent patients):
•Connect the ventilator to AC power whenever possible. In the event of battery failure, connect to AC power immediately to resume ventilation.
•For ventilator-dependent patients, use an external power source (Astral External Battery or RPSII battery) including when AC power is unavailable or interrupted.
•Use an external power source in mobile situations. Do not rely solely on the internal battery for mobile use.
•Ensure the external battery source is sufficiently charged before using in mobile situations.
•For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device.
•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.
•Return the ventilator to a service provider if it displays any notifications of battery issues or significant degradation in battery performance.

If you have any questions or concerns about this issue, speak to the supplier of your device or your local service provider. Alternatively, contact ResMed on 1300 305 705.

Supplier
ResMed Limited
Where the product was sold
Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category