Events

Alerta De Seguridad para Olympic Cool-Cap® System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Natus Medical Incorporated.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-05-29
  • Fecha de publicación del evento
    2012-05-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120529b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Natus Medical Olympic Cool-Cap® System
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated