| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00257-1 |
| Product Name/Description |
BiPAP Devices
BiPap A30
BiPAP A40
BiPAP A40 EFL
BiPAP A40 Pro
Model numbers: 1076581, 1076582, 1076583, 1111145, 1111171, AUX3000S19, AUX3100S19, 1111145, 1111171
ARTG's 133794, 200289, 329407, 329408 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
The A30 and A40 series bi-level positive airway pressure (BiPAP) devices may experience interruptions and/or loss of therapy with the potential for unexpected shut down due to a Ventilation Inoperative Alarm.
This problem 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.
The device will remain inoperable until a hard reboot is completed which may temporarily fix the problem.
This action supersedes the Product Defect Alert issued in April 2024. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact customers to discuss device replacement with an alternate Philips device or alternative options.
In the interim patients/users are to:
- If a Ventilator Inoperative Alarm Occurs ensure the patient is connected to an alternative source of ventilation. Contact your home care equipment provider for service and/or an alternative device.
- As an optional step, customers may attempt a “hard reboot” that MAY temporarily restore device function until an alternative device is sourced (instructions in the customer letter or www.Philips.com.au).
- This can take approximately 60 seconds to perform
HCPs are to assess whether the patients under their care can tolerate interruptions of therapy to ensure they continue to receive the most appropriate therapy. Further instructions are provided in the customer letter.
If further information is required, or if customers haven't heard from Philips, contact Philips on 1800 830 517 or clinical-philips@easyconnectsrc.zendesk.com. |
| Contact Information |
1800 830 517 - Philips Customer Support |