FDA advice concerning Enclosed Bed Systems manufactured by Vail Products
Reference No.: 1542/05
Vail enclosed bed systems are canopy-like padded beds covered with nylon netting that is zipped into place.
Vail Enclosed Bed System
They are used for at risk patients, both adults and children, with cognitive impairment, unpredictable behaviour, spasms, seizures and other disorders. The beds are used as an alternative to a physical or drug restraint to reduce falls from a bed and prevent patients from wandering.
FDA is aware of approximately 30 entrapments in these systems, of which at least 7 resulted in death.
FDA advises to stop using Vail enclosed bed systems.
Distribution is said to be USA, Canada and Saudi Arabia. Explicit information, that these beds have not been distributed in Europe and Germany was not available. Thus, BfArM forwards this information with reference to the FDA’s advice.
According to the German medical devices act, supervision of users and facilities is a matter of the Federal Competent Authorities.
In case of questions please contact:
Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Facsimile: +49 228 207-5300
E-Mail: medizinprodukte@bfarm.de
Telephone: +49 228 207-5306 (Active and in vitro diagnostic medical devices)