| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01388-1 |
| Product Name/Description |
Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz Controllers
Serial Numbers: CR600003 to CR604302 and CU200002 to CU200072
Manufacturing date range is from March 2015 – March 2017
ARTG Numbers: 239273 and 239274 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Hill-Rom has become aware of a potential issue with some International (220 - 240 V, 50 Hz) Compella Air Surfaces. Within the Low Air Loss mattress, a hose in the foot section is prone to kinking and occluding air flow. This can result in heat rising and failure of the air compressor inside the Compella Controller. If the compressor fails, the Controller can no longer function correctly to maintain air flow to the Compella mattress, in which case the Controller will alarm. To date, there have been no reported patient safety related complaints associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hill-Rom is advising users that the affected systems will be corrected as a permanent fix. The systems can continue to be used until the correction has been completed.
This action has been closed out on 05/11/2018 |
| Contact Information |
1800 445 576 - Hill-Rom Technical Support |