This paper proposes a method to analyze statistically maintenance data for complex medical devices with censoring and missing information. It presents a classification of the different types of failures and establishes policies for analyzing data at the system and component levels taking into account the failure types. The results of this analysis can be used as basic assumptions in the development of a maintenance/inspection optimization model. As a case study, we present the reliability analysis of a general infusion pump from a hospital. Copyright © 2010 John Wiley & Sons, Ltd.