Natus Medical Incorporated Olympic Cool Cap System Class I Recall

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Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall – Control Screen Freezes During Treatment

AUDIENCE: Risk Manager, OB/GYN, Pediatrics

ISSUE: FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, 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.

All serial numbers are affected by this recall.

BACKGROUND: The Olympic Cool Cap System (Cool-Cap) is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) 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 Cool-Cap is used with clinical evidence of moderate to severe HIE. The Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.

RECOMMENDATION: On May 16, 2012, Natus Medical Incorporated sent its customers an URGENT: MEDICAL DEVICE letter with an attached Field Safety Notice. The letter describes the product, problem, and the actions taken. Natus is coordinating the replacement of power supplies in all affected Olympic Cool-Cap Cooling Modules and will be contacting each of their customers to schedule the power supply replacement. Customers can call Natus Technical Service at 1-888-496-2887 for any questions about this recall.

Read the MedWatch safety alert, including a link to the Recal Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331853.htm

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