| Vail enclosed bed systems are canopy-like padded | | | | or younger. |
| beds with a padded mesh dome that fits over and | | | | A week later, Vail mailed warning labels and revised |
| encloses the beds. They are used in home-care and | | | | instruction manuals for its 500, 1000, and 2000 |
| clinical situations as an alternative to drugging or | | | | models and, on June 30, 2005, it initiated a recall of |
| restraining patients with seizures, spasms, cognitive | | | | approximately 5,000 of the canopied or enclosed bed |
| impairments, or unpredictable behavior that may lead | | | | systems. |
| them to fall from their bed or wander. | | | | The FDA had twice previously warned Vail Products, |
| On March 22, 2005,however, the U.S. Food and Drug | | | | Inc. that they were engaging in unacceptable |
| Administration (FDA) ordered U.S. Marshals to seize | | | | practices. They pointed out that the enclosed bed |
| hospital beds manufactured by Vail Products, Inc. | | | | systems posed a health danger even when used as |
| because they posed a significant risk to consumers | | | | prescribed, and that there were inadequate warnings |
| and did not meet the Quality System regulations of | | | | and directions for use. Vail then failed to take |
| the federal Food, Drug and Cosmetic Act. The | | | | corrective actions after having been given an |
| Marshals have also seized bed systems and | | | | opportunity to do so. They also failed to provide the |
| components in the manufacturing and distribution | | | | FDA with information and materials required by |
| phase, as well as labeling and promotional materials. | | | | Reports of Corrections and Removals and Medical |
| On June 16, 2005, the Toledo, Ohio manufacturer | | | | Device Reporting regulations. |
| publicly announced that it would discontinue | | | | If your loved one has suffered an injury or death |
| manufacturing, selling and distributing all of its | | | | you suspect was as a result of using a Vail enclosed |
| enclosed bed systems, and would no longer provide | | | | bed system, you should contact an experienced |
| replacement parts, retrofit kits, or accessories. At | | | | product liability attorney to assess your case and help |
| least 30 patients had suffocated when becoming | | | | you determine if you are entitled to compensation. |
| trapped between the mattress and the bed’s | | | | You can identify the Vail 500, 1000, and 2000 models |
| railing or had fallen from the beds, often resulting in | | | | of the enclosed bed systems by the model number |
| brain damage and at least eight deaths. Most of | | | | found on the label, which is on the front of the bed |
| these incidents involved children sixteen years of age | | | | or on one of the legs. |