Events

Alerta De Seguridad para NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device

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

¿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
    2014-09-23
  • Fecha de publicación del evento
    2014-09-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140923.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: bedfont scientific noxboxi inhaled nitric oxide delivery and monitoring device the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning noxboxi inhaled nitric oxide delivery and monitoring device, manufactured by bedfont scientific. the manufacturer noticed that some operators of the noxboxi nitric oxide delivery and monitoring device have been using components which have not been supplied or recommended by bedfont scientific. the manufacturer has provided a list of possible components which are not supplied by bedfont scientific. in the field safety notice. these components included calibration gas, sample lines / disposables, manual bagging accessories and transportation accessories. according to the manufacturer, using such supplied parts may damage the device and cause injury or in some cases death to the patient or the operator. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con455982 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 september 2014.

Device

NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bedfont Scientific NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
  • Manufacturer
    Bedfont Scientific

Manufacturer

Bedfont Scientific