According to a warning issued by the FDA, Philips Avalon Fetal Monitors could provide delivery room healthcare professionals false readings, leading to missed cases of fetal distress or unnecessary interventions, potentially causing a newborn to suffer a permanent injury.
In a letter sent to healthcare providers on September 4, the FDA indicated that Philips Healthcare has received complaints regarding inaccurate readings from Philips Avalon Fetal Monitors with ultrasound transducers. An Important Device Safety Alert was issued for fetal monitor models FM20, FM30, FM40 and FM50, and the FDA issued their follow up letter to ensure that the appropriate healthcare professionals receive the information.
If fetal monitor problems lead to inaccurate readings, it could result in unnecessary interventions or prevent healthcare providers from identifying signs of fetal distress. According to the FDA, the problems most commonly occur during the second stage of delivery.
The Philips Avalon Fetal Monitors are used to track the heart rate of infants during delivery using ultrasound, and similar devices have been in use since the 1970s. Incidents where the monitors report the fetal heart rate at half speed, double speed, or accidentally switches between the fetus’s heart rate and the mother’s heart rate have been known problems for years, according to the letter. Philips has also received reports of the audible fetal heart rate (FHR) differing from the printed FHR trace, and reports of a delay in the display of the FHR when transducers have been repositioned.
Fetal distress can occur before or during childbirth when the fetus appears to be fatigued or suffering from erratic, high or low heart rates. Causes can range from breathing problems, placental abruption, umbilical cord prolapse and other problems. Some cases of fetal distress, particularly those resulting from breathing problems and a lack of oxygen to the infant’s brain, can result in cerebral palsy, learning disabilities, seizures and mental retardation.
To avoid false readings which could cause health care professionals to miss signs of fetal distress, or cause them to take extraordinary measures due to false readings, delivery room staff have been encouraged to confirm readings with obstetric stethoscopes, Doppler or ultrasound imaging. According to a statement released by Philips, if there is an abrupt change in heart rate of the fetus, healthcare professionals should consider monitoring the maternal heart rate to make sure the device isn’t reading the mother’s heart rate instead of the child’s. They can also use a fetal scalp electrode to confirm the readings are from the fetus.