Philips Avalon Fetal Monitors, Models FM20, FM30, FM40 and FM50
Date: 04-Sep-2009
Dear Healthcare Provider,
Philips has recently received a number of complaints of inaccurate readings when using the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40, and FM50 with the ultrasound transducer. Inaccurate output readings, if not properly addressed, may lead to:
- Unnecessary interventions
- Failure to identify the need for interventions
- Failure to identify fetal distress
The complaints most commonly occur during the second stage of labor and include reports of the following:
- Halving of the fetal heart rate (FHR)
- Doubling of the fetal heart rate
- Switching between the fetal and maternal heart rates
- Audible FHR output differs from the printed FHR trace
- Delayed FHR display when repositioning transducers
Recognizing these conditions and responding appropriately is important to avoiding serious adverse health consequences
Users should take the following steps to reduce risks, as described in the Instructions for Use:
- Confirm fetal life before using the monitor
- Obstetric stethoscope
- Doppler
- Ultrasound imaging
Continue to confirm that the fetus is the signal source for the fetal heart rate particularly if abrupt changes in fetal heart rate are noted
- Consider monitoring the maternal heart rate
- Consider using a fetal scalp electrode if a discrepancy is suspected
Fetal monitors utilize ultrasound technology to measure fetal heart rate non-invasively. This measurement method is standard and has been employed by the major worldwide manufacturers and suppliers of fetal monitors since the 1970s. The medical literature describes the known phenomena of halving and doubling of fetal heart rate and switching between fetal and maternal heart rate.
We urge you to review the Instructions for Use for the Philips Avalon Fetal Monitors. For your convenience, we have attached excerpts from the Instructions for Use describing halving, doubling and fetal/maternal heart rate switching. These excerpts should not substitute for full review of our Instructions for Use.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
If you require any additional assistance, please contact our Philips Customer Care Center at 800-722-9377.
Best regards,
Peter Ohanian
Sr. Director, Quality & Regulatory Affairs