Abstract: Objective To strengthen the monitoring of ventilators, and ensure the correct and safe use of the products. Methods By introducing the classification,common use, suspected medical device adverse event (MDE) and analyzed of the MDE causes of ventilators, the risk factors of ventilators were anlyzed. The analysis of the risk factors was based on three aspects, including design factors, use factors and patients factors. Some advices to the risk control were suggested. Results The unreasonable design of products and improper use were the common risks about ventilators. Conclusion Manufacturers need to improve the product design, operators need to improve training to control the risks of ventilators.

Key words: ventilator, medical device adverse events monitoring, risk factor, analysis