Events

Alerta De Seguridad para defibrillators cardiolife TEC-8300K series

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

¿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
    2012-08-14
  • Fecha de publicación del evento
    2012-08-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120814a.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: nihon kohden defibrillators cardiolife tec-8300k series the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of defibrillators cardiolife tec-8300k series (model no.: tec-8321k, tec-8322k, tec-8332k, tec-8342k and tec-8352k), manufactured by nihon kohden corporation. according to the manufacturer, there is a possibility for a limited number of cardiolife defibrillators tec-8300k series that the battery is not charged when the defibrillator is connected to the ac power. the defibrillator can be used in the battery operating mode until the battery is discharged completely. there is no limitation for the operation of the defibrillator when ac power is connected. 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 affected product, please contact your supplier for necessary actions. posted on 14 august 2012.

Device

defibrillators cardiolife TEC-8300K series
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Nihon Kohden defibrillators cardiolife TEC-8300K series
  • Manufacturer
    Nihon Kohden Corporation

Manufacturer

Nihon Kohden Corporation