Philips Avalon Fetal Monitors
Audience: Obstetric healthcare professionals, hospital risk managers
FDA issued a Dear Healthcare Provider Letter 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].
[09/04/2009 - Dear Healthcare Provider Letter - FDA]