Events

Alerta De Seguridad para Graseby MR10 Neonatal Respiration Monitor

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Smiths 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
    2011-12-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111213.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
    Field safety notice: smiths medical graseby mr10 neonatal respiration monitor the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice advising users of a voluntary correction of a limited number of graseby mr10 neonatal respiration monitors. medical device manufacturer, smiths medical, has identified that the three battery straps in the mr10 battery box can become permanently deformed, causing the batteries to make only intermittent contact. if this condition occurs during use, then the mr10 may stop functioning without producing an audible alarm. if this condition occurs during an apnoea event, and if it is not observed that the indicator light is no longer lit, this could result in serious injury or death. 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.

Device

Graseby MR10 Neonatal Respiration Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smiths Medical Graseby MR10 Neonatal Respiration Monitor
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical