The FDA and Natus Medical Inc. are recalling the Olympic Cool-Cap System. This device consists of a cooling “cap” that is placed on the head of infants who are at risk of brain damage due to severe oxygen deprivation during birth. The problem is that the Control Module can lose power and may fail to deliver cooling treatment. This could potentially result in severe injuries, including permanent brain damage, disabilities, or death.
Need an Olympic Cool-Cap System Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If your child or a loved one injured by the Olympic Cool-Cap System, you should contact our lawyers immediately. You may be entitled to compensation by filing a Olympic Cool-Cap System lawsuit.
What is the Olympic Cool-Cap System?
The Olympic Cool-Cap System is a medical device that is manufactured by Natus Medical Inc. The product consists of a “cap” that is used to cool the head of an infant. The system also provides radiant heat to warm the infant’s body.
The Cool-Cap is used to treat hypoxic-ischemic encephalopathy (HIE), a type of brain injury that occurs due to asphyxiation (severe lack of oxygen) during a difficult birth. The Cool-Cap provides mild hypothermia to the brain, which can reduce or prevent brain damage. HIE occurs in about 1-8 per 1,000 live births, and can cause permanent disabilities or death.
What is the problem?
The Cool-Cap System is supposed to provide 72 hours of monitored cooling. However, the power system on the Control Module can fail without warning, causing the system to freeze during treatment. The screen may still display patient information, but the clock in the upper right-hand corner may stop displaying.
If the system loses power, it may fail to begin treatment or suddenly stop providing cooling treatment for an infant.
The FDA warns:
“This product can cause serious adverse health consequences, including death.”
Olympic Cool-Cap System Recall
Natus Medical Inc. initially recalled the Cool-Cap System on May 16, 2012. At the time, they notified their customers by sending an Urgent Product Notification and a Field Safety Notice, which described the problem. The company is currently working to replace the power system on the devices.
On December 12, 2012, the FDA issued a Class 1 Recall of the Cool-Cap System, which involves all lots of the device. The FDA reserves Class 1 recalls for products that have a “reasonable probability” of causing serious injury or death.
Do I Have an Olympic Cool-Cap System Lawsuit?
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