| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00836-1 |
| Product Name/Description |
Centrella Smart+ Bed
Product Code: P7900B1SPL06
All serial numbers with software version 1.27.000
ARTG 312121
(Hill-Rom Pty Ltd - Centrella Smart+Bed with Therapy Surface - Bed, general-purpose, electrical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare Corporation is issuing an Urgent Product Defect Correction for Centrella Smart+ beds with system software version 1.27.000 due to the potential for an interface problem with the Rauland Responder 5 Nurse Call System. The bed exit system will alert at the bed but may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.
If the bed exit alert fails to notify the caregiver at the assigned remote location (e.g., nurse’s station) the staff may be unaware the patient exited the bed if they are unable to hear the local bed alert.
As a result, a patient may experience a fall resulting in a critical musculoskeletal injury, including head trauma.
To date, Baxter has not received any reports of patient injury related to this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Baxter will be upgrading the software on all Centrella Smart+ beds with the affected software version to resolve the problem.
To mitigate the patient risk associated with this software problem, customers using the Rauland Responder 5 Nurse Call system are to ensure the bed exit alert is silenced at the bedside first before silencing the alert at the in-room nurse call wall unit. |
| Contact Information |
1800 445 576 - Baxter Healthcare |