| TGA Action ID |
RC-2025-RN-00545-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Invacare Birdie lifter and Invacare Birdie Compact lifter
All manufactured units |
| ARTG Number |
166395 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
After becoming aware of a serious adverse event related to the Invacare Birdie lifter and carabineer attachment, Invacare is reminding customers of the importance of ensuring the correct assembly position of the carabiner in the Birdie lifter arm, as well as the correct attachment of the hanger bar into the carabiner.
Invacare is also updating the Maintenance Checklist included in the Instructions For Use of the device. An additional point has been added to check the hanger bar during regular maintenance under “The hanger bar” section. Images have also been included to show the correct and incorrect carabiner positions. |
| Instructions for Customers/Users |
Customers are reminded to verify that the carabiner always remains in the correct assembly position.
The carabiner should not be able to rotate within the plastic parts where it is assembled without resistance. If unimpeded rotation occurs, this indicates the plastic parts present wear and need to be replaced.
Providers/distributors must inform all affected users of this action.
Customers are to store the Addendum with the current Birdie Lifter Instructions For Use, and use the updated Maintenance Checklist for performing the regular maintenance of the device. |
| Action Commencement Date |
2/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 460 460 - Invacare Australia |