Centrella Smart+ Bed

Issue

Baxter Corporation is issuing an urgent medical device correction for Centrella Smart+ beds with system software version 1.27.000 due to the potential for an interface issue 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 issue. Recall start date: September 19, 2024