title: US Food and Drug Administration: adverse event reporting.
abstract: 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.
authors.affiliation: US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD, USA.
authors.forename: A A
authors.initials: AA
authors.lastname: Graham
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000776:Anesthesiology / Q000295:instrumentation*; D004869:Equipment Safety; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012121:Respiration, Artificial / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration