FDA Requests Response from Invacare–Beds are Burning

The FDA has requested additional information relative to complaints about the electric run beds catching on fire. In August the factor in Florida was inspected and violations were found and now the FDA has given the company a 15 day time frame to respond. One patient allegedly died from an incident with one of their beds. BD

The Food & Drug Administration slaps Invacare Corp. with a warning letter for failing to adequately address reports of fires, sparks and entrapment from electric beds that in some cases allegedly resulted in patient deaths.

Invacare Corp. (NYSE:IVC) was slapped with a warning letter by federal regulators for failing to adequately investigate reports of fires and sparks from electric beds that in some cases allegedly resulted in patient deaths.

The warning letter from the Food & Drug Administration contains several disturbing consumer complaints related to Invacare’s adjustable beds, including one in April about a fire that started at the foot of a bed and resulted in a consumer’s death.

The violations cited by the FDA came to light during an August inspection of a plant in Sanford, Florida. Invacare was cited for a host of record-keeping violations at the plant, including failing to document the manufacturing steps needed to prevent the production of faulty or “nonconforming” product.

FDA warns Invacare on burning beds | MassDevice - Medical Device Industry News