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- Olympic Cool Cap Service Manuals
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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.
The Olympic Cool-Cap®. The operating instructions in this manual are intended for use under the direction of a licensed physician and by practitioners who have been trained in the use of Cool-Cap.
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?
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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.
A medical head-cooling system for newborns is being recalled because of a software problem, which may cause it to fail while treating infants.
Olympic Cool Cap Service Manual 2016
The Olympic Cool-Cap System recall was announced by the FDA on December 12, impacting selective head cooling systems for full-term infants suffering from hypoxic-ischemic encephalopathy (HIE), which are manufactured by Natus Medical.
Natus originally sent out an Urgent: Medical Device letter to its customers in May, alerting them that the screen on the Control Module of the device can freeze. This means that despite information being shown on-screen that the caps are working, the infant may not be receiving cooling treatment.
This week the FDA determined that the letter constituted a Class I medical device recall, the highest designation a recall can receive. The Class I designation means that the FDA believes the cooling cap problem creates the reasonable probability that a patient will suffer severe injury or death. However, there have been no injuries or deaths reported in relation to the Olympic Cool-Cap problems.
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Olympic Cool Cap Service Manual 2017
The recall affects the Olympic Cool-Cap System, catalog/part number 60010, distributed between January 18, 2007 through April 20, 2012. The recall affects all serial numbers.
The caps are cooling water caps placed on the head of the infant while the body is warmed with radiant warmers. When working properly the caps provide 72 hours of monitored cooling for moderate to severe cases of HIE to prevent or reduce neurologic injury.
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Customers with questions should contact Natus Technical Service at (888)496-2887.
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Tags: Children, Medical Device Recall