It has come to our attention that medical device manufacturer, Liko AB (A Hill-Rom company) has issued a field safety notice regarding all serial numbers of bathing chair with the following model numbers: 3156025 and P3156025.
The Liko Bathing Chair is an accessory to overhead lift devices. An event occurred in a public pool area in Sweden where it was alleged that a patient fell out of the chair during a lift. The patient allegedly suffered serious injuries.
The complaint investigation revealed the device was used without securing the safety belt, which is designed to keep the patient stabilized in the chair during the lift. The safety belt is secured to the chair and cannot be moved. It cannot be unnoticed to be used as part of the safe use of the device. The manufacturer has assessed the risk not likely to occur again in the lifetime of the device.
The manufacturer has created a label reminding users to secure the patient with the safety belt and a new user instruction guide on how to safely use the chair. A modification kit including the label and an updated user guide will be sent to affected users.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 10 October 2012