Federal regulators have issued a warning to Invacare Corp., an Ohio manufacturer of electric beds, for failing to report and address consumer complaints about its electric beds — including allegations involving three deaths after fires or entrapment, as reported in the Cleveland Plain Dealer.
On January 4, 2011, The U.S. Food and Drug Administration posted a Dec. 15 warning letter to the company on the FDA website. According to an FDA spokeswoman, the agency issues warning letters when it finds that manufacturers have “significantly violated” FDA regulations. Failure to resolve the cited violations can lead to enforcement actions by the agency.
The letter cited about several complaints about Invacare’s electric beds between February and July 2010. The most serious allegations included reports that:
• An 11-year-old died after the youngster was entrapped between the bed and bed rail.
•A women suffocated after her head got stuck between the rail and mattress.
• A patient died after a fire started at the foot of the patient’s bed.
Other complaints involved complaints of a “burning smell” and “visible flames” from motorized components.