Events

Alerta De Seguridad para nFlow Infant Nasal CPAP Breathing System

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

¿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
    2014-10-14
  • Fecha de publicación del evento
    2014-10-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141014b.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: intersurgical nflow infant nasal cpap breathing system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning nflow infant nasal cpap breathing system, manufactured by intersurgical. the affected ref numbers were 4700000, 4700001, 4700003, 4700004, 4700006, 4700007, 4700008, 4700009, 4700010, 4700014, 4700016, 4700017, 4700020, 4700150, 4760000 and 4761000. the affected lot numbers were from 31400042 till 31458271. there is a small possibility that the inspiratory tube or monitoring line tube may detach from the nflow generator. this will result in loss of ventilation or its monitoring. the manufacturer advises affected users to quarantine and destroy the above lot numbers. alternatively if the products are required urgently, users are advised to inspect the product to make sure there is a noticeable amount of glue where the tube goes into the generator (patient end connector). furthermore, users are advised to monitor the system continuously during use. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con462307 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 october 2014.

Device

nFlow Infant Nasal CPAP Breathing System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Intersurgical nFlow Infant Nasal CPAP Breathing System
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical