| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00961-1 |
| Product Name/Description |
Babytherm 8004/8010 and Babytherm 8000WB for newborns (Infant warmers and open infant care units)
ARTG Number: 121161 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Dräger have become aware of a case in which a side panel on a Babytherm 8010 did not fully slide to the bottom in the corner guide and was not completely locked. The side panel did not open during this incident and no patient was affected. As part of the review, Dräger identified that the inner 70mm panels were not always used however, the inner 70mm panels are part of the safety concept of the Babytherm 80XX. If contrary to the information provided in the Instructions for Use Manual the inner panels are not inserted and if a side panel has not been fully locked into position this may allow the baby’s movements to open the side panel. It may be possible for a child to fall out. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are reminded to pay attention to the information provided in the Instruction for Use Manual: i.e., “Check that the side panels lock securely into position and that they remain securely locked”. If the locking mechanism is not functioning or the inner panels are missing or damaged, please contact Dräger Customer Service to arrange correction. This action has been closed-out on03/02/2017. |
| Contact Information |
03 9244 7248 - Drager Medical |