Take Precautions with Audible Alarms on Ventilators
MedSun: Newsletter #65, October 2011

FDA Medical Device Safety

In 2010, the FDA received over 2,500 adverse event reports associated with ventilator use. About a third of these events indicated an alarm-related issue. Although some of these alarm-related adverse event reports reflected deteriorating patient condition, indicating that the ventilator alarms had functioned appropriately, many indicated preventable audible ventilator alarm malfunctions or human error.

Additional Information:

FDA Medical Device Safety. Take Precautions with Audible Alarms on Ventilators. September 6, 2011.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm270894.htm


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