| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00533-1 |
| Product Name/Description |
BiPAP A40 Pro Ventilators, BiPAP A40 EFL Ventilators, and BiPAP A30 EFL Ventilators
Multiple Products and Model Numbers
ARTG 329408, 329407 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips Respironics is advising about a potential safety problem with all BiPAP A40 Pro Ventilators, BiPAP A40 EFL Ventilators, and BiPAP A30 EFL Ventilators which are currently subject of an existing corrective action: RC-2024-RN-00257-1.
These ventilators may incorrectly generate a “High Internal Oxygen” alarm and inaccurately report elevated oxygen levels to the device when elevated levels are not present.
When this happens, it can cause the device to incorrectly detect elevated oxygen concentration, even when supplemental oxygen is not connected to the device.
The device will continue to provide therapy while the alarm is addressed (in accordance with the User Manual). This problem can manifest itself in the following forms:
·The device continuously raises the “High Internal Oxygen” alarm, while supplemental oxygen is connected.
·The device continuously raises the “High Internal Oxygen” alarm, while supplemental oxygen is not connected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
• All alarms must be responded to following the instructions provided by the device User Manual.
• Any patient that is dependent on their device should have suitable backup therapies available in the event of a device malfunction. This includes situations where an alarm cannot be cleared.
• Remove the patient from the device and switch to an alternative therapy device if a “High Internal Oxygen” alarm that cannot be cleared is experienced.
•Contact your device distributor/healthcare provider if an alarm or malfunction that cannot be resolved following the device User Manual is experienced.
Philips Respironics is currently investigating this problem and will implement appropriate actions to prevent recurrence. |
| Contact Information |
1800 830 517 - philips@easyconnectsrc.zendesk.com - Philips Customer Support |