(b)(6) is the distributor of the device which is a (b)(6) branded pressure prevention system that is designed to provide continuous rotation at the required patient levels.(b)(6) became aware of the incident through legal action.We have no access to the device for investigation nor any of the required data for this report.The end-user was paralyzed from the waist down and was using the device to prevent bed sores/ulcers.The device was serviced multiple times by the provider since its first use in (b)(6) 2015.Two weeks after the last repair the end-user was sitting on the end of the bed eating when he was reportedly thrown from the bed.He suffered multiple broken bones in his legs.Following surgery to one leg two days later the end-user passed away.
|