Events

Alerta De Seguridad para Avance CS2

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

¿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
    2013-04-05
  • Fecha de publicación del evento
    2013-04-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130405.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: ge healthcare avance cs2 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning avance cs2, manufactured by ge healthcare. the avance cs2 may experience an intermittent display unit failure while in use, which could result in unexpected system performance and may include the loss of mechanical ventilation and balance gas delivery (medical air or n2o). according to the manufacturer, users may continue to use avance cs2, however in the event the display goes blank, users should stop use of the device and contact local ge healthcare representative. if the display goes blank, an audible alarm will notify the user of the loss of mechanical ventilation. below are the avance cs2 safety precautions in place if this should occur: alt o2 automatically activates, continuing to flow o2 and agent concentration (prevailing setting) at the previous setting to the patient breathing circuit. manual ventilation is available. furthermore, ge healthcare will correct all affected systems. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con252005 if you are in possession of the product, please contact your supplier for necessary actions. posted on 5 april 2013.

Device

Avance CS2
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare Avance CS2
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare