Vail Enclosed Bed Systems

Vail enclosed bed systems are canopy-like padded beds with a padded mesh dome that fits over and encloses the beds. They are used in home-care and clinical situations as an alternative to drugging or restraining patients with seizures, spasms, cognitive impairments, or unpredictable behavior that may lead them to fall from their bed or wander.

On March 22, 2005,however, the U.S. Food and Drug Administration (FDA) ordered U.S. Marshals to seize hospital beds manufactured by Vail Products, Inc. because they posed a significant risk to consumers and did not meet the Quality System regulations of the federal Food, Drug and Cosmetic Act. The Marshals have also seized bed systems and components in the manufacturing and distribution phase, as well as labeling and promotional materials.

On June 16, 2005, the Toledo, Ohio manufacturer publicly announced that it would discontinue manufacturing, selling and distributing all of its enclosed bed systems, and would no longer provide replacement parts, retrofit kits, or accessories. At least 30 patients had suffocated when becoming trapped between the mattress and the bed’s railing or had fallen from the beds, often resulting in brain damage and at least eight deaths. Most of these incidents involved children sixteen years of age or younger.

A week later, Vail mailed warning labels and revised instruction manuals for its 500, 1000, and 2000 models and, on June 30, 2005, it initiated a recall of approximately 5,000 of the canopied or enclosed bed systems.

The FDA had twice previously warned Vail Products, Inc. that they were engaging in unacceptable practices. They pointed out that the enclosed bed systems posed a health danger even when used as prescribed, and that there were inadequate warnings and directions for use. Vail then failed to take corrective actions after having been given an opportunity to do so. They also failed to provide the FDA with information and materials required by Reports of Corrections and Removals and Medical Device Reporting regulations.

If your loved one has suffered an injury or death you suspect was as a result of using a Vail enclosed bed system, you should contact an experienced product liability attorney to assess your case and help you determine if you are entitled to compensation. You can identify the Vail 500, 1000, and 2000 models of the enclosed bed systems by the model number found on the label, which is on the front of the bed or on one of the legs.

You can find additional information on the seizure of the enclosed beds at: [http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01347.html]

If you have questions for the FDA, you may contact:

E-mail: phann@cdrh.fda.gov

Fax: 240-276-3356

Telephone: 240-276-3357 (leave message)

Correspondence: Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850

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