| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01287-1 |
| Product Name/Description |
Invacare Birdie Lifters (Patient lifters)
Lifter Birdie (180KG-EL-JC)
Item Number: 3000503.E3B00-0125
Lifter Birdie (170KG EL)
Item Number: 3000502.E3B00-0125
Lifter Birdie CMPT (150-ML-JC)
Item Number: 3000513.D3B02-0125
Lifter Birdie Compact (150KG ML)
Item Number: 3000512.D3B02-0125
Lifter Birdie MAN (170KG-ML-JC)
Item Number: 3000503D3B02-0125
ARTG Number: 166395 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Invacare are updating the instructions for use with respect to correct assembly of the D-Clip that connects the actuator to the Birdie lifter’s arm. As a result of some reports overseas where the actuator’s D-Clip becomes damaged and the lifter arm falls down, Invacare have become aware that if the D-Clip is always placed backwards and pointing down towards the actuator (incorrect assembly), it can start to become damaged after a number of cycles. If the D-Clip becomes damaged to the extent that the lifter arm falls down then there is potential for a serious patient injury to occur.
When the clip is in the wrong position the bending (damage) of D-Clip only happens if it is touching the actuator backwards and at its maximum height. The clip will also bend severely when over 140kg is used with the device. The complete Clevis Pin (quick release pin) doesn’t detach immediately from the actuator when the D-Clip becomes damaged - the pin stays in the arm’s plates that hold the actuator. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Invacare is advising customers that the following should be checked on each Birdie Lifter.
1. The actual state of the D-clip - does it appear bent or broken? If the D-clip is damaged or broken, Invacare should be contacted and they will provide replacement stock.
2. The actual position of the D-clip in the lifter. If it is in the correct position, there is no need to change it. If it is assembled in the wrong position, the D-clip should be removed and reassembled according to the directions that are being provided.
Revised instructions for use are avaliable.
This action has been closed out on the 29/10/2018. |
| Contact Information |
1800 460 460 - Invacare |