Approximately 5,000 "enclosed" bed systems manufactured by Vail Products, Toledo, Ohio, have been recalled because of their potential to cause patient entrapments, the Food and Drug Administration said. Such entrapments can result in severe neurological damage from asphyxiation or death.
The FDA, which first issued a public health notification about the beds' risk in March, said it is aware of approximately 30 entrapments, resulting in at least eight deaths. The agency has advised hospitals and consumers to stop using the bed system if possible. Vail has sent new instruction manuals and warning labels to every customer, and users were advised by the FDA to follow these safety precautions if no alternative beds were available.
Vail Chief Executive Officer Joy Vail said the company was caught off guard by the FDA's recall and has not had time to devise an action plan.
Vail enclosed bed systems are canopylike padded beds covered with zipped, nylon netting. They are used as an alternative for at-risk patients requiring physical or drug restraint.