FDA WARNING_LETTER - CHG Hospital Beds, Inc. - April 29, 2011

An FDA inspection of CHG Hospital Beds, Inc. in London, Ontario, from April 26-29, 2011, revealed that their Spirit hospital beds are misbranded under section 502(t)(2) of the Act. This misbranding stems from the firm's failure to furnish material or information required by section 519 of the Act and 21 CFR Part 803, the Medical Device Reporting (MDR) regulation. Significant violations include the failure to submit an MDR within 30 days for a serious injury (a patient's broken hip after falling from a bed with a malfunctioning nurse call alarm), as required by 21 CFR 803.50(a)(1). Although an MDR was later submitted for this specific event, the initial failure constituted a violation. Additionally, the firm failed to develop, maintain, and implement adequate written MDR procedures, as required by 21 CFR Part 803.17. Deficiencies in the procedures included a lack of standardized processes for determining reportable events, insufficient definitions, inadequate documentation and record-keeping instructions, and incomplete guidance for timely report submission. The firm's May 11, 2011, response and revised procedure were deemed inadequate. CHG Hospital Beds, Inc. must notify the FDA within fifteen working days of specific corrective actions, prevention plans, and a timetable for completion. Failure to correct these violations will result in federal agencies being advised, potentially impacting contract awards, and Certificates to Foreign Governments will not be granted.