Document Detail


US Food and Drug Administration: adverse event reporting.
MedLine Citation:
PMID:  9866488     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
A A Graham
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  CRNA : the clinical forum for nurse anesthetists     Volume:  9     ISSN:  1048-2687     ISO Abbreviation:  CRNA     Publication Date:  1998 Nov 
Date Detail:
Created Date:  1998-12-31     Completed Date:  1998-12-31     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9109511     Medline TA:  CRNA     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  135-8     Citation Subset:  N    
Affiliation:
US Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD, USA.
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems*
Anesthesiology / instrumentation*
Equipment Safety
Humans
Product Surveillance, Postmarketing / statistics & numerical data*
Respiration, Artificial / adverse effects*
United States
United States Food and Drug Administration*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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