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Federal marshals yesterday raided an East Toledo manufacturer of enclosed hospital beds because a federal Food and Drug Administration investigation has determined that 30 patients became trapped in the bed and at least seven of them died.
The beds, manufactured by Vail Products, 235 First St., pose a "significant health risk" because patients can become trapped and suffocate, resulting in brain damage or death, according to an FDA statement.
Marshals seized all finished Vail model 500, 1000, and 2000 enclosed beds at the facility, as well as components, labeling, and promotional materials. The FDA, which is responsible for the safety and oversight of medical devices such as hospital beds, said the seizure was the result of "ongoing concerns" about the beds' safety.
Joy Vail, chief executive officer of Vail Products, declined direct comment and issued a written statement yesterday afternoon indicating that company officials were provided with a copy of the complaint but "have not had time to thoroughly review it and investigate its allegations."
Responding generally to the government's assertions, the firm stated, "We strongly disagree that our products are unsafe or dangerous when used as directed. We believe that when they are used as directed, our products are beneficial to several groups of patients who are vulnerable and at risk. We also disagree with the government's allegation that the labeling and instructions for the products are inadequate."
Vail makes padded, mesh domes that fit over and "enclose" a bed used in clinical and home-care situations. The dome can be zipped shut to prevent the patient from falling or wandering away.
The FDA contends that Vail's "enclosed bed systems" are misbranded and place patients at risk because of the instructions given with the beds. The FDA, in its statement, urged those who have purchased those enclosed bed systems to stop using them until they receive further instruction from Vail.
The agency stated that Vail Products failed or refused to furnish material to the FDA as required by federal law, and said Vail has continually not followed FDA regulations. Vail has been issued two FDA warning letters - one in 1997 and one in 2003 - outlining unacceptable practices. The agency says Vail was given a chance to correct violations but failed to do so.
FDA spokesman Kathleen Quinn said she had little information about the investigation beyond the FDA statement, but said "there's been ongoing concerns about the quality of the products."
Last month, the parents of a girl with cerebral palsy who died while using a Vail bed sued the firm, saying Vail knew the bed had safety problems but did not inform them of a recall. The suit claims Victoria Flick, 7, died after getting stuck between the mattress and a railing of the bed in August, 2004. Her parents, John and Deborah Flick, are seeking at least $75,000 in damages.
Robert Vail, the company's president and his wife, Joy, told The Blade for a 1995 article that the company was founded in 1990. The Vails are also founders of the Vail Meadows Therapeutic Riding Center, an Oregon facility that uses horses as part of a therapy program for those with neurological conditions.
Staff Writer David Patch contributed to this report.
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