2 Dec 2011
Re: FDA Warning Letter Issued to CHG Hospital Beds Inc., August 29, 2011
The FDA was at CHG Hospital Beds Inc. from April 26th to 29th to conduct a routine inspection covering the FDA’s Quality System / Current Good Manufacturing Practice Regulations for Medical Devices as documented in 21 CFR Part 820.
There was one finding during the inspection. It was:
A Medical Device Report was not issued to the FDA within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
The complaint in question involved a patient climbing over locked side rails, falling, and breaking a hip. CHG did not submit an MDR to the FDA because there was no bed malfunction, but because the bed made it possible for the patient to climb over the rails and seriously injure themselves, the FDA considers the bed to have contributed to the serious injury.
To correct this finding an MDR was immediately submitted to the FDA to report the incident, and the related CHG procedure was revised and submitted to the FDA to address the inspection findings.
On August 29, 2011, the FDA issued a Warning Letter to CHG which stated that our response regarding the MDR submission was adequate because an MDR was submitted, but also stated that our MDR procedure was not adequate. To correct this problem, a new CHG procedure was implemented and submitted to the FDA which now addresses all FDA definitions and MDR requirements.
On November 2, 2011, the FDA issued a closure letter, attached, stating that our response, which included a revised Medical Device Reporting procedure, was adequate.