Natus Medical, a newborn care and neuro-diagnostic product manufacturer based in San Carlos, California, received Class I recall status from the United States Food and Drug Administration (FDA) for its Olympic Cool Cap System. The Olympic Cool Cap System is designed to prevent or reduce neurologic injury in infants.

According to a notice by the FDA, the Cool Cap is designed for use in infants with hypoxic-ischemic encephalopathy, a disease that causes very low oxygen levels in the brain. The device is designed to cool the brain by several degrees. Since lower temperatures slow down electro-chemical and physiological processes in the body, reducing brain temperature is an effective way to slow down the rate of brain damage during hypoxic events. Similar technologies are currently available for adults.

In its Class I recall notice, the federal watchdog agency’s most serious category, the FDA notes that the device is prone to screen malfunctions that lead to improper notifications. These notifications can cause the device to seem like it is working when it is not. This can lead to adverse events like severe brain damage or death.

The company first made customers aware of the problem in May of this year. It is currently in the process of replacing faulty power supply units that caused the improper notifications. During the recall, the FDA requests that physicians and patients report problems through its MedWatch system.

References

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm331834.htm