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U.S. Department of Health and Human Services

Safety

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Vail 500, 1000, and 2000 Enclosed Bed Systems

Audience: Hospital and Extended Care Facility Administrators, Risk Managers and consumers

[03/23/2005] FDA and the Department of Justice initiated seizures of all finished Vail 500, 1000, and 2000 Enclosed Bed Systems made by Vail Products, Inc., in a response to ongoing concerns about manufacturing quality and labeling. Use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death. FDA is aware of approximately 30 entrapments resulting from use of the Vail Enclosed Bed Systems, of which at least 7 resulted in death. FDA advises consumers to stop using Vail 500, 1000 and 2000 Enclosed Bed Systems until they receive additional instructions from Vail Products.

[UPDATE 06/24/2005] - Vail Products is permanently ceasing the manufacture, sale and distribution of all Vail enclosed bed systems, and will no longer be available to provide accessories, replacement parts, or retrofit kits. On June 23 and 24, 2005, revised instruction manuals and warning labels were mailed to customers with Vail 500, Vail 1000 or Vail 2000 enclosed bed systems. The revised manuals include new warnings, precautions, and instructions for use. FDA is advising hospitals, nursing homes and consumers who have a Vail enclosed bed system to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home can consult with their physicians about other options.

[March 25, 2005; UPDATED June 24/2005 - Preliminary Public Health Notification - FDA]
[June 30, 2005 - Recall Notice - FDA]
[June 30, 2005 - Press Release - FDA]