Wednesday, March 23, 2005
On behalf of the FDA, U.S. Federal marshals have begun seizing beds which have killed at least seven patients out of about 30 who had become trapped by the products. Three versions of the bed were found to be “dangerous to health” by the FDA, with the specific danger of, “placing patients at an increased risk of entrapment and asphyxiation.”
The model numbers of the faulty beds include the Vail 500, 1000, and 2000 Enclosed Bed Systems. The beds are made by Toledo, Ohio-based Vail Products, Inc.
In a government press release, the FDA pointed out that Vail had failed to heed two previous warnings issued by the agency, asking the company to comply with regulations regarding proper labeling and usage directions. The FDA also said that Vail had failed to supply required documentation to the agency to comply with the Medical Device Reporting and Reports of Corrections and Removals regulations.
At the time this story was filed, the Vail web site made no mention of today’s FDA announcement. Toledo’s WTOL News 11 reported that, “Company officials say their beds aren’t dangerous if used properly.” The Vail corporate web site claims that the beds allow, “the patient to move about freely within a safe, padded environment” and “control wandering.”
The FDA is the U.S. agency responsible for regulating food, drugs, medical devices, and cosmetics.