Natus Medical Inc. and the U.S. Food and Drug Administration (FDA) have announced a Class 1 Recall of all lots of the Olympic Cool-Cap System. The device is a “cap” that cools the head of infants who are born with brain damage due to lack of oxygen during birth. Unfortunately, the Control Module on the device can suddenly lose power, and it may fail to provide cooling treatment for an infant. The FDA warns that this defect could potentially cause severe injury or death.
What You Can Do & How an Olympic Cool-Cap System Recall Lawsuit Can Help
The Schmidt Firm, PLLC is currently investigating Olympic Cool-Cap System induced injury cases in all 50 states. If you or somebody you know has been injured by the Olympic Cool-Cap System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
What is the Olympic Cool-Cap System?
Natus Medical Inc. manufactures the Olympic Cool-Cap System, a medical device that is used to cool the head of infants with hypoxic-ischemic encephalopathy (HIE), while simultaneously warming the infant’s body with radiant heat. The device provides 72 hours of monitored cooling.
The Cool-Cap treats HIE by inducing mild hypothermia to the infant’s head, which can prevent or reduce the severity of brain damage due to HIE.
HIE occurs in about 1-8 per 1,000 live births, usually when the birth is very difficult and the child suffers asphyxiation due to severe lack of oxygen. The condition is associated with a high risk of brain damage, long-term disabilities, and death.
What is the problem?
The problem is that the Olympic Cool-Cap Control Module can freeze during treatment. Patient information remains displayed on the screen, but the Cool-Cap is not actually providing cooling treatment for the infant. The clock displayed in the upper right-hand corner of the display screen may stop displaying.
The power failure can occur without warning, causing the system to fail to begin or continue providing cooling treatment.
According to the FDA:
“This product can cause serious adverse health consequences, including death.”
FDA Recall of the Olympic Cool-Cap System
On December 12, 2012, the FDA issued a Class 1 Recall of the Olympic Cool-Cap System. The recall affects all of these devices that have been sold. The FDA only issues Class 1 recalls when there is a good probability that the defective device will cause serious injury or death.
Natus Medical Inc. sent its customers an Urgent Product Notification and Field Safety Notice on May 16, 2012. The notifications described the problem with the device. The company is currently in the process of fixing power supplies on the recalled Cool-Cap Systems and notifying all of their customers about the recall.
Do I have an Olympic Cool-Cap System Lawsuit?
The Schmidt Firm, PLLC is currently investigating Olympic Cool-Cap System induced injury cases in all 50 states. If you or somebody you know has been injured by the Olympic Cool-Cap System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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