Natus—neoBLUE Blanket Systems: Fiber-Optic Pads May Fail

March 25, 2015 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a Technical Bulletin letter submitted by an ECRI Institute member hospital, Natus states that it has received reports of early failure of the blanket system fiber-optic pads below. The failures involve discoloration/degradation followed by eventual melting of the fiber-optic bundle at the connector that is inserted in the neoBLUE blanket light box. The firm states that this failure occurs after extended exposure to the intense light source within the box, at which time the pad no longer provides the therapeutic treatment for which it is intended. Natus also states that the failure occurs because of heat buildup at the fiber-optic cable connector inside the neoBLUE blanket light box. This may be accompanied by a hot plastic smell; however, because the device is constructed of fire-retarding materials, there is no danger of fire. This localized heating is internal to the light box and does not affect the patient or the caregiver. The manufacturer has not confirmed the...

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