This study details all incidents involving medical devices used in anaesthesia and intensive care reported to the relevant authorities in France in 1998. There were 1004 reports during that year. Incidents were classified as serious (harmful to patients) in 11% of cases; death resulted in 2% of cases. Equipment for ventilation and infusion, and monitors of all kinds, accounted for most of the reports, representing 37%, 30% and 12%, respectively, of all reports. The leading causes of failure varied according to the category of device. User errors, quality control problems during production of the device and design faults were the three main causes. The problems identified during the study period enabled the faulty medical devices to be improved in 12-44% of cases. We conclude that post-marketing vigilance is a useful way of improving the quality of medical devices.

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