FDA cites reports of fire with Invacare beds
Federal health regulators have issued a warning to Invacare Corp. for failing to report and address malfunctions with its electric beds, including electronics that allegedly caught on fire causing injury and death.
The Food and Drug Administration posted a warning letter to the Ohio-based company online Tuesday morning. Invacare makes a variety of medical equipment, including wheelchairs, oxygen tanks and electric beds.
In its Dec. 15 warning letter, the FDA said the company has repeatedly failed to document and investigate recurring complaints with its adjustable beds. Between April and July last year, the company received four complaints involving sparks or fires that were reportedly triggered by its beds. In one case, "an Invacare bariatric bed caught fire and two patients were taken to the hospital and treated for smoke inhalation and chest pain." Another report references a fire that started at the foot of a bed, causing a patient's death.
Other complaints involve patients getting stuck between the mattress and bed rail. In one case the problem allegedly caused the death of an 11-year-old child. Invacare failed to submit similar complaints reported in 2009. Elsewhere, inspectors reported that Invacare's customer service representatives have not been trained to document problems reported by customers.
FDA inspectors uncovered the problems during a routine inspection in August. Soon afterward, Invacare told the agency it would conduct a new analysis on the risks for patients becoming trapped in its beds. But according to the FDA letter, Invacare representatives "have not provided any evidence of implementation of this corrective action."
The agency calls on Invacare to report back on its plans for correcting the problems within 15 working days of receiving the letter.
Calls placed to Invacare Tuesday morning were not immediately returned.
The FDA regularly issues warning letters to companies that don't follow regulations for manufacturing and marketing drugs, medical devices and other products. The letters are not legally binding, but the FDA can take companies to court if they are ignored.
Shares of Invacare Corp. fell $1.02, or 3.3 percent, to $29.65 in morning trading.