Alarming Monitor Problems
MedSun: Newsletter #63, August 2011

FDA Medical Device Safety

A search of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database yielded 566 alarm related death reports from 2005 to 2008. Follow-up investigations often showed that users weren't familiar with how the monitoring equipment worked or hadn't checked the monitor's alarm status. This article includes precautions that users can take to help prevent these issues.

Additional Information:

FDA Medical Device Safety. Alarming Monitor Problems. September 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm222022.htm


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