Abstract: The U.S. Food and Drug Administration(FDA) implemented a new device problem codes in July 2009. In this paper, we presented an overview of the device problem codes and their structure, demonstrated device problem codes' practical significance to medical device risk assessment using the Manufacturer and User Facility Device Experience(MAUDE) database, discussed the difficulties in applying the device problem codes to China considering the current conditions of medical device adverse events monitoring, and made suggestions for implementation using the device problem codes for reference. The objective of this paper was to provide some helpful information for establishment of the medical device failure terminology in China.

Key words: FDA, device problem codes, medical device failure, terminology, risk assessment