FDA Gives Invacare a 483, Citing Corrective Actions

Invacare failed to take adequate corrective action in response to reports of patients being trapped in its medical beds, sometimes resulting in death, a recent Form 483 says. In one instance, a patient was found with her head in the left side of the rail, face down in the mattress, the form says. Invacare’s investigation of the March 2009 complaint was inadequate because it did not document its attempt to get information on the mattress involved, make a good faith effort to get information about the complaint and determine the most likely root cause. The company is following through with all FDA requests, Invacare spokeswoman Lara Mahoney said.
The GMP Letter