{"title":"美国食品和药物管理局:不良事件报告。","authors":"A A Graham","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":77087,"journal":{"name":"CRNA : the clinical forum for nurse anesthetists","volume":"9 4","pages":"135-8"},"PeriodicalIF":0.0000,"publicationDate":"1998-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"US Food and Drug Administration: adverse event reporting.\",\"authors\":\"A A Graham\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":77087,\"journal\":{\"name\":\"CRNA : the clinical forum for nurse anesthetists\",\"volume\":\"9 4\",\"pages\":\"135-8\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1998-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CRNA : the clinical forum for nurse anesthetists\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CRNA : the clinical forum for nurse anesthetists","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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.