Philips Avalon Fetal Monitors Producing Inaccurate Readings, FDA Warns Doctors

The Food and Drug Administration has sent a “Dear Doctor” letter to healthcare professionals to warn about complaints the agency has received regarding inaccurate readings while using certain models of Philips Avalon Fetal Monitors.

The FDA issued an Important Device Safety Alert about the products, which are used to monitor maternal pulse rate and blood pressure, fetal heart rates, uterine activity, and fetal movement. Some users of the devices have complained about inaccurate output readings, most often during the second stage of labor, the FDA warning notice said.

Failing to address improper readings can lead to unnecessary interventions, failing to take action when intervention is necessary, and an inability to recognize fetal distress, the FDA warned. Serious adverse health consequences to fetuses and mothers may result from these complications.

Philips Avalon Fetal Monitors models FM20, FM30, FM40, and FM50 with the ultrasound transducer are the subject of the FDA safety warning. The FDA is offering steps users should use to minimize the risks of inaccurate readings and encouraging users to review the instructions for use of the fetal monitors.

Defective medical devices present a serious risk of severe injury and death to millions of patients each year. Monitors, pain pumps, defibrillators, and similar products are used to administer life-saving treatments to heart patients, newborns, and others. When they fail to work properly due to defective design, the risk of injury and death dramatically increases.

No related posts.