Events

Alerta De Seguridad para Neonatal and Paediatric Endotracheal Tube Clamp/Holder

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

¿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
    2012-07-25
  • Fecha de publicación del evento
    2012-07-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120725.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: ems medical neonatal and paediatric endotracheal tube clamp/holder the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device safety alert concerning all neonatal and paediatric endotracheal tube clamp/holder manufactured by ems medical. according the mhra, the composition of the plastic used to make the clamp/holder was changed to a dehp-free material. this affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. based on the information provided by the mhra, ems medical has gone into administration before this issue was identified and it is not known how many affected devices have been supplied. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2012.

Device

Neonatal and Paediatric Endotracheal Tube Clamp/Holder
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: EMS Medical Neonatal and Paediatric Endotracheal Tube Clamp/Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    DH