A recall notice for Stellar 100 and Stellar 150 Portable Ventilators supplied by ResMed Ltd.
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:
- The device has a failed Q64 electronic component and,
- The device is stored without AC power connected for more than 36 hours leading to full depletion of the battery; and,
- The device powers on automatically when connected to AC power without pressing the power switch.
If the device is used on a ventilator dependent patient, an alarm or failure condition may present a risk of injury or even death.
ResMed Ltd - Stellar 100 and Stellar 150 Portable Ventilators
PRA No.
2019/18023
Date published
13 Dec 2019
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)
Identifying features
SKU
24156, 24164, 24147, 24162
What are the defects?
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:
- The device has a failed Q64 electronic component and,
- The device is stored without AC power connected for more than 36 hours leading to full depletion of the battery; and,
- The device powers on automatically when connected to AC power without pressing the power switch.
What are the hazards?
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 should consumers 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.
Supplier
Where the product was sold
Nationally
International
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.
Product category
