This action supersedes the product correction issued in June 2024.
What is the problem?
Due to ongoing problems with their A30 and A40 series bi-level positive airway pressure (BiPAP) devices, Philips is now contacting affected customers and patients to organise replacement devices or discuss alternative options.
The affected BiPAP devices may stop providing therapy on an intermittent or permanent basis and the ‘Ventilator Inoperative’ alarm will sound.
All the following devices are affected:
- BiPAP A30
- BiPAP A40
- BiPAP A40 EFL
- BiPAP A40 Pro.
It is important to note that BiPAP A30, BiPAP A40, and BiPAP A40 Pro devices are not intended for life support and are not intended to ventilate patients suffering from respiratory failure.
What should patients do?
- For patients who cannot tolerate interruption or loss of therapy, including patients who use a BiPAP A40 Pro device for more than 8 hours a day and/or who are invasively ventilated, an alternative ventilator is required.
This determination should be made under the guidance of a physician, noting that appropriate compensation may be offered rather than an alternative device.
- For patients who can tolerate interruptions in therapy they should contact Philips Customer Support on 1800 830 517 or clinical-philips@easyconnectsrc.zendesk.com, regarding alternate device options.
In the meantime, if the ‘Ventilator Inoperative’ alarm occurs, you can perform a ‘hard reboot’ which may temporarily fix the problem while you wait for an alternative device from the equipment supplier.
The reboot can take approximately 60 seconds to perform.
Please visit the Philips web page for steps on how to perform a hard reboot.
What should health professionals do?
Assess whether the patients under your care can tolerate interruptions to their therapy.
If interruptions of therapy cannot be tolerated, consider writing a prescription for an alternative ventilator.
More information
If you need further information or support concerning this problem, contact Philips Customer Support on 1800 830 517 or clinical-philips@easyconnectsrc.zendesk.com.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.