Attempting to guarantee the quality of cardiac defibrillators, a study was performed at a Brazilian public hospital applying the Health Care Failure Mode and Effect Analysis. Although this technique was developed for applications within the healthcare process, it can be adapted for usage by the clinical engineering to identify the failure modes of medical equipment and to assess the involved risks. Through this study, problems that interfere with the performance of cardiac defibrillators were identified and, subsequently, some actions were proposed to help reduce the risks of these potential problems. These actions certify the safe functioning of this device within the standards of safety and quality. Copyright © Lippincott Williams & Wilkins.312108113(1996) Risk Analysis, Healthcare Risk Control (HRC), 3, pp. 1-10Stalhandske, E., DeRosier, J., Patail, B., Gosbee, J., How to make the most of failure mode and effect analysis (2003) Biomed Instrum Technol, 37, pp. 96-102Emergency Care Research Institute (ECRI) An introduction to FMEA, using failure mode effects analysis to meet JCAHO's proactive risk assessment requirement (2002) Health Devices, 31, pp. 223-226Emergency Care Research Institute (ECRI) Hospitals tackle new JCAHO requirement with failure mode and effects analysis (2002) Risk Manag Report, 21, pp. 1-7Grissinger, M., Rich, D., JCAHO: Meeting the standards for patient safety, a focus on medication safety is required under Joint Commission tandards, and tools are available to help pharmacists achieve the best possible outcomes (2002) J Am Pharm Assoc, 42 (1 SUPPL.), pp. S54-S55Florence, G., Calil, S.J., Application of HFMEA Technique in the Determination of Medical Device Risk [on CD-ROM] (2004) III Latin-American Congress on Biomedical EngineeringDeRosier, J., Stalhandske, E., Bagian, J.P., Nuddel, T., Using Health Care Failure Mode and Effect Analysis™: The VA National Center for Patient Safety's Prospective Risk Analysis System, Joint Commission for Accreditation of Healthcare Organizations (2002) J Qual Improv, 28, pp. 248-267Jones, P.L., Jorgens III, J., Taylor, A.R., Weber, M., Risk management in the design of medical device software systems (2002) Biomed Instrum Technol, 36, pp. 237-266(2001) Defibrillators, External, ManualDefibrillator/ Pacemakers, External, Healthcare Product Comparison System - HPCS, pp. 3-4Suporte Avançado de Vida em Cardiologia (1997) American Heart Association, pp. 4.1-4.20. , ISBN 0-87493-634-9