Product description
Stellar 100 and 150 Portable Ventilators (Medical Device)
Product Numbers: 24156, 24164, 24147, 24162.
Serial Number Range 20160123307 to 22171057208
Manufactured between April 2016 and June 2017
ARTG 219429
(Resmed Limited - Portable ventilator, electric)
Product Numbers: 24156, 24164, 24147, 24162.
Serial Number Range 20160123307 to 22171057208
Manufactured between April 2016 and June 2017
ARTG 219429
(Resmed Limited - Portable ventilator, electric)
See a list of details to help identify the product
Reason the product is recalled
The audible alarms may not operate properly. Alarms will display on the screen of the Stellar device.
Due to a Q64 electronic component failure on the Stellar device, the identified issue is a combination of software and a component failure.
The alarm buzzer may not work under the following combined circumstances:
1. The device has a failed Q64 electronic component and,
2. The device is stored without AC power connected for more than 36 hours leading to full depletion of the battery; and,
3. The device powers on automatically when connected to AC power without pressing the power switch.
Due to a Q64 electronic component failure on the Stellar device, the identified issue is a combination of software and a component failure.
The alarm buzzer may not work under the following combined circumstances:
1. The device has a failed Q64 electronic component and,
2. The device is stored without AC power connected for more than 36 hours leading to full depletion of the battery; and,
3. The device powers on automatically when connected to AC power without pressing the power switch.
The hazards to consumers
If the device is used on a ventilator dependent patient, an alarm or failure condition may present a risk of injury or even death.
What consumers should do
Consumers should use the product consistent with the indications for use (i.e. Stellar is not a life support device). Prior to use consumers should perform a functional test including alarms as described in the ‘Starting therapy’ section in the User guide. Press the power switch at the back of the device once to turn on the device. Check that the alarm sounds a test beep and the LEDs (visual indicator) for the alarm signal and the Alarm mute button flash. Stellar remains safe for use when used as indicated and following the user guide.
ResMed is developing a device correction to address this issue (expected March 2020). When this is available ResMed will contact affected customers.
For further information, contact ResMed on 02 8884 1430.
ResMed is developing a device correction to address this issue (expected March 2020). When this is available ResMed will contact affected customers.
For further information, contact ResMed on 02 8884 1430.
Details to help identify the product
Supplier running the recall
Identifying numbers
SKU
24156, 24164, 24147, 24162
Where the product was sold
Nationally
International
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2019/18023 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.