Events

Alerta De Seguridad para Defibrillation Electrode SKINTACT DF29N

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

¿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
    2016-09-20
  • Fecha de publicación del evento
    2016-09-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160920.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 defibrillation electrode skintact df29n the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning defibrillation electrode skintact df29n manufactured by leonhard lang. the affected article number is 50028. during an investigation triggered by customer feedback, the manufacturer discovered that it can be aggravated to connect these defibrillation electrodes with the defibrillator welch allyn aed 10. as a consequence, it may happen that the user does not connect the electrodes with the defibrillator in an emergency situation. according to the manufacturer, there is a risk that the affected electrodes will be connected with the defibrillator only with delay or not at all. this may cause a situation in which a patient, who is in a life-threatening condition and requires a defibrillation shock, cannot be treated in good time. the manufacturer advises users to quarantine and destroy all unused affected products. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-12-16-september-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 september 2016.

Device

Defibrillation Electrode SKINTACT DF29N
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Leonhard Lang Defibrillation Electrode SKINTACT DF29N
  • Manufacturer
    Leonhard Lang

Manufacturer

Leonhard Lang