The Food and Drug Administration issued Invacare Corp. a warning letter for failure to fully address reports of fires and entrapment involving beds made by the company.
In a Dec. 15 warning letter, the FDA said Invacare, which makes a variety of medical equipment used in homes and long-term care facilities, didn't properly handle or investigate reports of fire and patients becoming trapped in beds.
The letter to the Elyria,Ohio, company was posted Tuesday on the agency's website.
The agency cited at least four reports of fires and three reports of entrapments that occurred in 2010, some of which resulted in patients dying. The warning letter stemmed from an FDA inspection of Invacare's Sanford, Fla., facility, which was conducted in August. Some of the fires appeared to start in the bed's control box, according to the letter.
FDA said the company didn't document actions needed to correct and prevent additional problems. The agency noted that Invacare responded to FDA's concerns in September, but the agency said that response "is not adequate."
In a statement, Invacare said the letter takes issue with the company's compliance with FDA regulations involving the proper handling of product complaints. The company said it would address all of FDA's concerns.
"Invacare wants to assure users and the general public that we rigorously test our products and stand fully behind the safety of our products," said Gerald B. Blouch, Invacare's chief executive. "The FDA warning letter does not state that our products are unsafe nor has it impacted our production."