Events

Alerta De Seguridad para CDI Blood Parameter Monitoring System 500

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

¿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
    2011-09-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110930.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
    Field safety notice: terumo cvs cdi blood parameter monitoring system 500 medical device manufacturer, terumo cardiovascular system (terumo cvs), has issued an urgent field safety notice concerning cdi blood parameter monitoring system 500 distributed during the period october 2009-may 2011. during functional testing, terumo cvs identified a defective integrated circuit on the main circuit board in the cdi blood parameter monitoring system 500. this integrated circuit could potentially cause cdi system 500 not to function after a loss of power, either upon intentional power down or due to an unexpected power outage. in this case, the monitor would display error codes upon restart, and would not be useable. there have been no confirmed complaints from cdi system 500 users on this issue. according to the local supplier, hk is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

CDI Blood Parameter Monitoring System 500
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo CVS CDI Blood Parameter Monitoring System 500
  • Manufacturer
    Terumo Cardiovascular System

Manufacturer

Terumo Cardiovascular System