Events

Alerta De Seguridad para Continuum MR Infusion System - Pump

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

¿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
    2014-03-26
  • Fecha de publicación del evento
    2014-03-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140326a.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: medrad continuum mr infusion system - pump health canada has issued a medical device safety alert concerning continuum mr infusion system - pump, manufactured by medrad inc. the affected lot numbers are 3008236, 3009135, 3009917 and 3009966. the manufacturer has identified that there have been incidents resulting in magnetic attraction caused by a damaged locking pin. the locking pin is found in the pump retaining bracket and is used to securely hold the pump in the bracket in the mr environment. the manufacturer has advised users to cease use of affected products immediately and remove the product from the mr scan room. for details, please visit the following health canada website:http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38611r-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 march 2014.

Device

Continuum MR Infusion System - Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medrad Continuum MR Infusion System - Pump
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DH