The FDA notified health care professionals of a Class I Recall of the Olympic cool-cap system from Natus Medical Inc.
The Olympic Cool Cap system (Cool-Cap) is a selective head cooling system for the treatment of hypoxic-ischemic encephalopathy in full-term infants (at 36 weeks gestational age). A cooling water cap is placed on the infant’s head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling.
The company recalled the device because the device’s control module may experience a frozen screen during treatment. When this occurs, the on-screen information remains on display, but the system is not providing cooling treatment to the infants.
The visible clock displayed at the upper right-hand corner of the screen stops displaying. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment. This product may cause serious adverse health consequences, including death.
Click here to read the MedWatch safety alert.
Weekly Jolt, December 18, 2012
