WASHINGTON – U.S. marshals seized three types of beds from a Toledo, Ohio, company on Tuesday that federal regulators blamed for seven deaths.
The Food and Drug Administration said it was aware of about 30 people who were entrapped by the Vail Enclosed Bed Systems (search) made by Vail Products, Inc.
"Use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death," the FDA (search) said in a statement.
Company officials could not be reached for comment to respond to the FDA charge. The FDA said it had sent two warning letters to the company outlining unacceptable practices under government regulations. The company was given an opportunity to correct the violations but failed to take appropriate actions, the FDA said.
The beds seized were described as Series 500, 1000 and 2000 enclosed bed systems. The beds are frequently used for patients who have been identified as in need of physical restraints.
The FDA said that marshals also seized all labeling and promotional materials for the beds.
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