Events

Alerta De Seguridad para V series patient monitors

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

¿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
    2011-11-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111122.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
    Mhra field safety notice: mindray v series patient monitor the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that a software anomaly contained in the v series monitor manufactured by mindray. according to the manufacturer, in rare instances, a system database corruption may occur that may cause the v series monitor to reset. the system will return to monitoring after 90 seconds, however, the database corruption may persist. should the database corruption persist, established patient settings may be incorrect and established alarm settings, including those related to arrhythmias, may be incorrect or not available. patient data may not be displayed or only partially displayed. 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 products, please stop using them and contact your supplier for necessary actions.

Device

V series patient monitors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Mindray V series patient monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray