A Series Update

Urgent Product Defect Correction in Australia

Philips Respironics A40/A30 BiPAP Series 鈥� Australia

All serial numbers

Philips, following consultation with the Therapeutic Goods Administration (TGA), is conducting an update to the Urgent Product Defect Alert of Philips A40/30 BiPAP Series sent in April 2024. This action is now classified as an Urgent Product Defect Correction and includes additional customer actions and remediation being taken by us.The affected products feature a Ventilator Inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. This may manifest in the following ways:

When there are three (3) reboots within a 24-hour period, the device will enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present).
OR
The device may enter a Ventilator Inoperative state without a reboot preceding this condition.

Update November 2024: Philips Respironics is clarifying the labeled intended use of the BiPAP A40 and BiPAP A40 Pro by removing 鈥淩espiratory Failure.鈥� Refer to Appendix A1 (Click here for a copy)

Note: Philips Respironics is not pursuing design changes relevant to these products for this problem. Customer Action: If you still have active devices in your possession, and if you have not yet done so, please contact Philips Customer Support on 1800 830 517 or email clinical-philips@easyconnectsrc.zendesk.com to organise a suitable remediation.

What is Philips doing?

Philips Respironics is clarifying the labeled intended use of the BiPAP A40 and BiPAP A40 Pro by removing 鈥淩espiratory Failure.鈥� This clarification is intended to prevent potential misinterpretation as the product is not designed or intended for life support applications. For further information on the clarified intended use, please see Appendix A1: Intended use for BiPAP A40 BiPAP A40 Pro devices only.

Based on patient conditions, Philips Australia will offer the following remediation options to users:

1. Options for patients who Can Tolerate interruptions in therapy

Alternate Device: Independent of a Ventilator Inoperative alarm, at the discretion of the patient, caregiver or physician, the customer will be provided with an alternative therapy device (DreamStation BiPAP AVAPS), and the A-series device should be returned to Philips Respironics. This will be done with a method that minimises disruption in therapy.
If a Ventilator Inoperative alarm occurs, the hard reboot option can be performed and may restore device function. When performing the hard reboot, the patient should be removed from the device until therapy is restored. For detailed information, see section on, Instructions on Performing a Hard Reboot.
DreamStation BiPAP AVAPS Intended Use: The BiPAP AVAPS device is intended to provide non-invasive ventilatory support to Obstructive Sleep Apnea (OSA) and Respiratory Impairment patients weighing over 18 kg. This device may be used in the hospital or home.
Appropriate compensation will be offered. To discuss your options please contact Philips Customer Support on 1800 830 517 or email clinical-philips@easyconnectsrc.zendesk.com

2. Option for patients who Cannot Tolerate interruptions in therapy

Appropriate compensation will be offered, if you have not yet done so, please contact Philips Customer Support on 1800 830 517 or email clinical-philips@easyconnectsrc.zendesk.com to organise a suitable remediation.
If a Ventilator Inoperative alarm occurs and an appropriate life support ventilator is not available immediately, as a temporary measure, a hard reboot can be performed and may restore device function. When performing the hard reboot, the patient should be removed from the device until therapy is restored. For detailed information, see section on, Instructions on Performing a Hard Reboot.

What should patients do?

1. For Patients Who Can Tolerate Interruptions of Therapy:

If your physician has indicated you are a patient that can tolerate interruptions in therapy, please see the following options:
Submit a request at the following: contact Philips Customer Support on 1800 830 517 or clinical-philips@easyconnectsrc.zendesk.com, regarding alternate device options.
If a Ventilator Inoperative alarm occurs, the hard reboot option can be performed and may restore device function. When performing the hard reboot, the patient should be removed from the device until therapy is restored. For detailed information, see section on, Instructions on Performing a Hard Reboot.

2. For Patients Who Cannot Tolerate Interruptions of Therapy:

If your physician has indicated you are a patient that cannot tolerate interruptions in therapy, please see the following:
Contact your physician to expedite transition to an appropriate life support ventilator.
If a Ventilator Inoperative alarm occurs and an appropriate life support ventilator is not available immediately, as a temporary measure, a hard reboot can be performed and may restore device function. When performing the hard reboot, the patient should be removed from the device until therapy is restored. For detailed information, see section on, Instructions on Performing a Hard Reboot.
Philips is providing an alternative form of appropriate compensation. For further information and to discuss your remediation options please contact Philips Customer Support on 1800 830 517 or email clinical-philips@easyconnectsrc.zendesk.com.

Instructions on Performing a Hard Reboot

You (or someone taking care of you) can perform a 鈥渉ard reboot鈥� (or restart) on your ventilator which may allow for temporary usage of the device until you can be placed on an alternative ventilator.

If a Ventilator Inoperative alarm occurs, the display screen turns red and the Ventilator Inoperative message appears on-screen, as shown below.

Warning: Immediately remove the patient from the ventilator and if required, connect them to an alternate source of ventilation. Contact your home care equipment provider for service.

Meanwhile, as an option you may follow these steps to try to temporarily restore ventilatory function while waiting for a replacement device and/or professional medical intervention.

1. Power off the therapy device.

Press the Start/Stop button.

If the ventilator display is operational, the 鈥淧ower Off鈥� confirmation screen will appear, as shown below.

Select the button on the right side, 鈥淵es鈥� to shut off the device and silence the alarm.

2. Unplug the power cord from the wall or from the device itself.

3. Remove the battery from the therapy device.

Detachable Battery Pack

If the detachable battery pack is used, open the battery compartment at top of the detachable battery module accessory.
Lift battery out using release lever on top of the battery (see below).

Li Ion Battery Pack

If an external battery pack is used, unplug the battery pack cord from the back of the ventilator (see below).

4. Leave the battery disconnected from the ventilator for at least 30 seconds.

5. Reconnect the applicable battery in use.

6. Plug the power cord in to the wall or to the therapy device itself.

7. Power on the device by pressing the Start/Stop button

8. Once the ventilator powers back on, therapy may be restarted.

What should health professionals do?

Philips Respironics is recommending that physicians/healthcare professionals assess whether the patients under their care are able to tolerate interruptions of therapy to help ensure that they continue to receive the most appropriate therapy.