The FDA has issued a notice to health care facilities after receiving complaints of inaccurate output readings for the Philips Avalon fetal monitors, models FM20, FM30, FM40, and FM50 with the ultrasound transducer.
On September 4, Philips issued an Important Device Safety Alert advising users to review the instructions for use and providing steps that users can take to help minimize risk when using the monitors.
The inaccurate results most commonly occur during the second stage of labor. Inaccurate output readings may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress.
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, either online, by phone, (800) 332-1088, or by faxing FDA Form 3500 to (800) FDA-0178. Read the complete MedWatch 2009 Safety summary on the FDA’s Web site.