FDA WARNING_LETTER - Fukuda Denshi Co, Ltd - November 04, 2011

This FDA Warning Letter, dated April 2, 2012, was issued to Fukuda Denshi Co., Ltd. following an inspection from October 31 to November 4, 2011, in Tokyo, Japan. The inspection revealed that the firm's electrocardiogram monitoring equipment and software are misbranded under section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR) and nonconformities with Quality System (QS) regulations.

Key violations include: 1. **Failure to report deaths or serious injuries:** The firm failed to report information suggesting a device caused or contributed to a patient's death (e.g., complaint 3000006537), as required by 21 CFR 803.50(a)(1). 2. **Failure to report malfunctions:** The firm failed to report a device malfunction (e.g., complaint 3000007574, involving burning) that could cause serious injury if it recurred, as required by 21 CFR 803.50(a)(2). 3. **Inadequate MDR procedures:** The firm failed to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17), specifically lacking timely event identification, standardized review for reportability (including definitions for key terms),