Events

Alerta De Seguridad para Skintact DF32L and DF31L Defibrillation Electrodes for Children

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

¿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
    2014-12-02
  • Fecha de publicación del evento
    2014-12-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141202b.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: leonhard lang skintact df32l and df31l defibrillation electrodes for children the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning skintact df32l and df31l defibrillation electrodes for children manufactured by leonhard lang gmbh. below are the details of the affected products: 50018 skintact df32l with lot number 30513-0770 59945 skintact df31l with lot numbers 30425-0778 and 30516-0770 during an internal investigation triggered by market feedback, it was discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this potential malfunction can occur with electrodes after a duration of storage of about 2 years or more. the precise cause of this is still under investigation. as this potential malfunction could lead to a lack of, or delay in, providing therapy with potentially serious consequences including death and serious injury, the manufacturer is recalling all lots of these electrodes older than 18 months. other electrodes which show a faultless performance can be used as usual according to the instructions for use. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con477294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2014.

Device

Skintact DF32L and DF31L Defibrillation Electrodes for Children
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Leonhard Lang Skintact DF32L and DF31L Defibrillation Electrodes for Children
  • Manufacturer
    Leonhard Lang GmbH

Manufacturer

Leonhard Lang GmbH