Date: September 4, 2009
Dear Healthcare Provider:
On September 4, 2009, Philips Healthcare (3000 Minuteman Road, Andover, MA 01810) issued an Important Device Safety Alert for the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40 and FM50. We are bringing this alert to your attention so that you can inform your constituents and help ensure this important information is received by the appropriate healthcare professionals.
The Philips Avalon Fetal Monitors, Models FM20, FM30, FM40 and FM50, utilize ultrasound technology to measure fetal heart rate non-invasively. Philips Healthcare received a number of complaints of inaccurate output readings that prompted this alert.
The alert describes potential outcomes if these inaccurate output readings are not properly addressed, the most common complaints reported, steps for the user to minimize the risk, and urges the user to review the Instructions for Use for Philips Avalon Fetal Monitors.
For additional information, please see Philip’s Healthcare’s Important Device Safety Alert at: http://www.healthcare.philips.com/us_en/support/fetal_monitor_notice.wpd
If you have observed adverse events with this product or other products, you may report them to MedWatch, the FDA Safety Information and Adverse Event Report program.