Events

Alerta De Seguridad para Neptune 2 Ultra Waste Management System

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

¿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
    2013-12-24
  • Fecha de publicación del evento
    2013-12-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131224b.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: stryker neptune 2 ultra waste management system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning neptune 2 ultra waste management system, manufactured by stryker. details of affected products are as follows: catalogue no.: 0702-001-000, 0702-002-000, 0700-001-000, 0700-002-000, 0700-003-000, 0700-007-000 lot no.: all the manufacturer has received four serious complaints where it was determined that the neptune rover had been connected to a passive chest drainage tube post-operatively resulting in patient haemorrhage. furthermore, the manufacturer advises users of the followings: quarantine the affected products until stryker is able to provide upgrades to units. ensure that the above mentioned devices are not used and alternative methods of suction should be sought. quarantined devices are recommended to undergo decontamination by a stryker field service representative to ensure there is no standing water or fluid left in the devices while they are in quarantine. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483 if you are in possession of the product, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

Neptune 2 Ultra Waste Management System

Manufacturer

Stryker
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH