Invacare Corp. has been warned by the Food & Drug Administration (FDA) for failing to report problems with its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">electronic beds. In a Warning Letter to Invacare, the agency said two deaths were linked to the malfunctioning beds, one of which occurred as a result of a fire.
This is not the first time an Invacare device has been linked to serious fires. In April 2000, Invacare issued a recall for six models of its <"http://www.yourlawyer.com/topics/overview/Wheelchair-fires">motorized wheelchairs because of fires and deaths linked to the devices. That recall was expanded to include a total of 16 models in September 2000. The recall included all powered wheelchairs Invacare made from 1985 to 2000 – more than 215,000 of them. According to a 2002 investigation by the Cleveland Plain-Dealer, Invacare waited years after reports surfaced that some of its wheelchairs were igniting, causing deaths and injuries, before issuing the recall.
In its Warning Letter issued on December 15, the FDA said Invacare 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,” the letter said. Another report references a fire that started at the foot of a bed, causing a patient’s death.
In other instances, patients reportedly became stuck between the mattress and bed rail. Once such incident resulted in the death of an 11-year-old child, the FDA said.
FDA inspectors uncovered the problems during a routine inspection in August, and the company said it would take corrective action. According to the letter, Invacare has since “not provided any evidence of implementation of this corrective action.”
The FDA is requiring that Invacare report back on its plans for correcting the problems with the electronic beds within 15 working days of receiving the letter.