MedSun: Newsletter #40, September 2009

Philips Avalon Fetal Monitors Print Item

FDA MedWatch Safety Alert

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.

Additional Information:

FDA MedWatch Safety Alert. Philips Avalon Fetal Monitors. September 4, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181505.htm

FDA Dear Healthcare Provider Letter. Philips Avalon Fetal Monitors. September 4, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181505.htm

Philip’s Healthcare’s Important Device Safety Alert
http://www.healthcare.philips.com/us_en/support/fetal_monitor_notice.wpd


abrir aquí para acceder al documento FDA completo:
MedSun: Newsletter #40, September 2009