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FDA Warning: Potential Inaccurate Readings on Fetal Monitors

Posted Sep 11 2009 10:04pm

My own side comment: even though my facility does not use this type of fetal monitor, these "problems" are an every day occurrence. Our monitors half/double/pick up maternal heart rates frequently. It's not all about the almighty machinery - it's about the nurse being competent enough to know how to use her eyes, hands and ears: how to look, feel and listen!


FDA Warns of Potential Inaccurate Readings by Philips Avalon Fetal Monitor

Emma Hitt, PhD

Published: 09/07/2009

September 7, 2009 — Fetal monitors made by Philips Healthcare, Avalon Models FM20, FM30, FM40, and FM50 and ultrasound transducer, may produce inaccurate readings, the US Food and Drug Administration (FDA) warned on Friday.

The manufacturer states that the inaccuracies most often occur during the second stage of labor and include the following:

  • Halving or doubling of the fetal heart rate (FHR)
  • Switching between the fetal and maternal heart rates
  • Differing audible FHR output compared with the printed trace
  • Delaying of FHR display upon repositioning of transducers

"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," according to an alert from MedWatch, the FDA's safety information and adverse event reporting program.

The device manufacturer recommends that users can reduce risks by confirming fetal life before using the monitor and also by using an obstetric stethoscope, Doppler, and ultrasound imaging, as per the instructions for use that accompany the device.

Clinicians should also "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." In addition, users should consult the instructions for use and consider monitoring the maternal heart rate using a fetal scalp electrode if a discrepancy is suspected, according to the manufacturer.

The Philips Customer Care Center can be contacted at 800-722-9377.

More information about the warning is available on the FDA's MedWatch site.

Adverse events related to the use of Philips Avalon Fetal Monitors should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Authors and Disclosures

Journalist

Emma Hitt, PhD

Emma Hitt is a freelance editor and writer for Medscape.

Disclosure: Emma Hitt, PhD, has disclosed no relevant financial relationships.


More info found here

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