The U.S. Food & Drug Administration (FDA) announced today that a nationwide recall has been issued for the Olympic Cool-Cap System, a device used to treat hypoxic-ischemic encephalopathy (HIE) in full-term infants. According to the FDA, the device’s control module may freeze up during treatment, and not provide cooling to the infants. This is a Class I Recall, which means that use of the Olympic Cool-Cap System could result in adverse health complications, including death.
Free Lawsuit Evaluation: If your child or other loved one was injured or killed after undergoing treatment with an Olympic Cool-Cap System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the Olympic Cool-Cap System and we can help.
What’s the Problem with the Olympic Cool-Cap System?
The Olympic Cool-Cap System recall was initiated after the FDA received numerous reports of the device’s control module experiencing a frozen screen during treatment procedures. When this occurs, the on-screen information remains on display, but the system is no longer cooling the infant. This power supply failure can happen without warning, and results in the system’s inability to begin or continue cooling treatment. All Olympic Cool-Cap serial numbers are affected by this recall.
Manufactured and marketed by Natus Medical Incorporated, the Olympic Cool-Cap System is a selective head cooling device used to treat full-term infants suffering from moderate to severe HIE. A cooling water cap is placed on the baby’s head, and the body is warmed with radiant warmers. The Cool-Cap is designed to provide selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE for up to 72 hours.
On May 16, 2012, Natus sent its customers an urgent letter describing the problem with the Olympic Cool-Cap, and what steps were being taken to correct the situation. The company is currently in the process of coordinating the replacement of power supplies in all affected models, and will be contacting each of the customers to schedule a power supply replacement.
Do I Have an Olympic Cool-Cap System Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Olympic Cool-Cap System recall lawsuits. We are investigating individual litigation nationwide and currently accepting new Olympic Cool-Cap System injury and death cases in all 50 states.
Free Olympic Cool-Cap System Recall Lawsuit Evaluation: If your child or other loved one was injured or killed after undergoing treatment with an Olympic Cool-Cap System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing an Olympic Cool-Cap System Recall suit and we can help.