| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00745-1 |
| Product Name/Description |
Compella Bariatric Bed System, Controllers and Air Surfaces
Model Number: P7800A
Compella Controllers
Product Number: P7810A
Manufactured between 25 March 2015 to 11 December 2015
Compella Air Surfaces
Product Number: P642A
Manufactured between 25 March 2015 to 25 September 2015
ARTG Numbers: 239273, 239274 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Hill-Rom has become aware of a potential issue with some Compella Air Supply Units and Air Surfaces. The Compella Air Supply Unit has been prone to inadequate pressure, which prevents the surface from achieving required settings for weight-based pressure redistribution. This also prevents the low air loss feature from operating. In addition, within the Low Air Loss surface, a hose in the foot section is prone to kinking, which can impact airflow to the topper and prevent the proper adjustment of the air bladders to relieve pressure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Hill-Rom representative will be contacting affected facilities to make arrangements for updating the affected capital Compella Air Supply Units and air surfaces. In the interim, Hill-Rom recommends customers to continue to use the product as they normally would. The mattress system will provide an alarm in the event the Compella Air Supply Unit or Air Surface does not operate properly. This action has been closed-out on 18/05/2017. |
| Contact Information |
1800 445 576 - Hill-Rom Technical Support |