Events

Safety Alert for Olympic Cool-Cap® System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Natus Medical Incorporated.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-05-29
  • Event Date Posted
    2012-05-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120529b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: natus medical olympic cool-cap® system 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.

Device

Olympic Cool-Cap® System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Natus Medical Olympic Cool-Cap® System
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated