FDA Recalls Olympic Cool-Cap System Due to Serious Health Risk
The U.S. Food and Drug Administration issued a Class I recall for the Olympic Cool-Cap System manufactured by Natus Medical Incorporated. The Cool-Cap is used for babies who have experienced Hypoxic-Ischemic Encephalopathy (HIE). HIE is an acute brain injury that can occur when the brain is deprived of oxygen during the labor and delivery process. The Cool-Cap lowers the temperature of the brain in an effort to prevent or reduce serious neurological damage associated with HIE.
Class I recalls are very serious in nature and are only issued when a device can cause serious harm or death to the patient. The recall was issued after it was discovered that the power supply can malfunction without warning and fail to provide cooling treatment for the infant. This defect puts babies at risk for severe injuries such as mental retardation, cerebral palsy, seizures, or death. All serial numbers are currently being recalled.
If you or someone you know had a child treated with the Olympic Cool-Cap System and suffered a severe injury,call us. Our product liability attorneys have fought for clients in a variety of defective medical device cases and have the skill and knowledge to help you obtain compensation for your damages.