Events

Alerta De Seguridad para Inspiration LS, and i Series Ventilator Systems

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

¿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
    2015-10-20
  • Fecha de publicación del evento
    2015-10-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151020.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: event medical inspiration ls, and i series ventilator systems the medicines and healthcare products regulatory agency (mhra) of united kingdom has posted a medical device safety alert concerning inspiration ls, and i series ventilator systems manufactured by event medical. all inspiration ventilators i series and ls 12.1" lcd built before 21 january 2015 are affected. according to the manufacturer, a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. this failure could result in death or serious injury to a patient. the manufacturer advises users to discontinue use of the affected ventilators immediately until correction is completed. the manufacturer also advises affected users to take the following actions:- for users who have the ls, 5i, or 7i inspiration ventilator system models subject to this field safety notice, the manufacturer has identified a correction to this issue which requires removal of the potentially faulty component from the power board. for users who have older models that are not the ls, 5i, or 7i model, these ventilators should be taken out of service. these models are no longer supported with spare parts or software versions and should be retired. for details, please refer to the mhra website:https://mhra.Filecamp.Com/public/file/2bog-sl9dth3p if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 october 2015.

Device

Inspiration LS, and i Series Ventilator Systems
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: eVent Medical Inspiration LS, and i Series Ventilator Systems
  • Manufacturer
    eVent Medical

Manufacturer

eVent Medical