Philips Issues Important Device Safety Alert about Avalon Fetal Monitors

FDA issues letter for healthcare providers.

FDA issued a Dear Healthcare Provider Letter (see below) to notify healthcare professionals and facilities of a number of complaints of inaccurate readings when using the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40, and FM50 with the ultrasound transducer. On September 4, 2009, Philips issued an Important Device Safety Alert. Inaccurate output readings, if not properly addressed, may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress. The complaints most commonly occur during the second stage of labor. Recognizing these conditions and responding appropriately is important to avoiding serious adverse health consequences.

The Philips alert describes 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.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by phone (1-800-332-1088), or by returning the postage-paid FDA Form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178).

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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.