Urgent Product Defect Correction in Australia

Philips Respironics A40/A30 BiPAP Series – 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.

What is Philips doing?

Philips Respironics is currently investigating this issue and will implement appropriate actions to prevent recurrence. In Australia, Philips Australia will be contacting affected customers and patients regarding the remediation. This includes replacement with an alternate Philips device or alternative options.

What should patients do?

If the ‘Ventilator Inoperative’ alarm occurs patients/caregivers are to:

Immediately remove the device from use and use an alternative device if available.
Contact their home care equipment provider for service and assistance.

Patients or caregivers may perform a “hard reboot” which may temporarily fix the problem while waiting for an alternative device from their equipment supplier.

This can take approximately 60 seconds to perform, and Philips is still performing testing to verify that the inoperation is cleared by the reboot and does not affect patient therapy.

Please see Instructions on Performing a Hard Reboot below.

Instructions on Performing a Hard Reboot

You (or someone taking care of you) can perform a “hard reboot” (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 “Power Off” confirmation screen will appear, as shown below.

Select the button on the right side, “Yes” 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?

Assess whether the patients under their care can tolerate interruptions of therapy to help ensure that they continue to receive the most appropriate therapy.

If interruptions of therapy can be tolerated and the ventilator inoperative (vent inop) alarm occurs:

the patient/caregiver is to remove the device and use an alternative device if available.
If they do not have an alternative device, they can contact their equipment provider for assistance with obtaining an alternative device.

If interruptions of therapy cannot be tolerated, please consider writing a prescription for a ventilator that is indicated for life supporting ventilation.

More Information

If you need further information or support concerning this problem, or if you have not heard from Philips, contact Philips Customer Support on 1800 830 517 or clinical-philips@easyconnectsrc.zendesk.com.

Anyone who is concerned in any way about the use of this product should consult their doctor.

Philips Respironics regrets any inconveniences caused by this problem. Please be assured that Philips Respironics has patient health and safety at the heart of what we do each and every day. We are committed to improving people’s health around the world.