| Reason for the Action |
Arjo has received 10 reports of events, including 7 injuries, where the side support opened unintentionally during use. Internal investigation showed that the side support of the Carevo shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. This can lead to a resident/patient fall and serious injury, such as head injury, fractures, or other trauma resulting from a patient fall.
Two factors have been identified which may lead to unintentional side support opening:
1. Incorrect or incomplete handle locking combined with user movement during handling. To support correct operation and reduce the likelihood of unintentional side support opening, the Instructions for Use have been updated to reinforce proper locking of both handles and the recommended ergonomic working posture.
2. For a subset of devices, the torsion springs may not always return the handle to its fully locked position. This may result in the handle remaining partially engaged, leading to unintentional side support opening if one handle is accidentally activated. |