美国食品和药物管理局:不良事件报告。

A A Graham
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引用次数: 0

摘要

本文回顾了1896年8月15日至1998年8月15日期间提交给美国食品和药物管理局的与麻醉装置相关的不良事件报告。心血管、普通外科和整形外科器械是最常报道的器械。死亡最常与心血管、综合医院和消化系统设备相关。与通风机相关的最常见的故障报告是音频或视觉报警系统的故障。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
US Food and Drug Administration: adverse event reporting.

This article reviews adverse event reports associated with anesthesia devices submitted to the US Food and Drug Administration during the period of August 15, 1896 to August 15, 1998. Cardiovascular, general surgical, and plastic surgical devices are the most frequently reported devices. Deaths are most frequently associated with cardiovascular, general hospital, and gastrourological devices. The most frequently reported failures associated with ventilators are failures of audio or visual alarm systems.

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