The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Olympic Cool-Cap System, manufactured by Natus Medical Incorporated.
The manufacturer of the device has initiated two separate field actions.
The first action applies to all Olympic Cool-Cap systems. The manufacturer has been informed of a small number of instances where the Olympic Cool-Cap system's Control Module has experienced a frozen screen during the treatment of infants. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infant. Although there is an audible alarm that sounds when this occurs, not all users have reported hearing it; the only visible indication on the system screen is that the clock displayed at the upper right hand corner of the screen stops advancing.
The second action applies only to a specific subset of Olympic Cool-Cap systems. The manufacturer has been informed of a small number of instances where the power supply within the Cooling Module of the Olympic Cool-Cap system has failed. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment. In response, Natus is proactively coordinating the replacement of power supplies in all affected Olympic Cool-Cap Cooling Modules.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the product, please contact your supplier for necessary actions.
Posted 29 May 2012