Alerta De Seguridad O Notificaciones De Seguridad para Neonatal and paediatric endotracheal tube clamp/holder

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por EMS Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2012/049
  • Número del evento
    CON174833
  • Fecha
    2012-07-23
  • Fecha de publicación del evento
    2012-07-23
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder. ems medical has gone into administration and therefore cannot be contacted.   the mhra has issued this medical device alert to ensure that all users are aware of this issue. 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. ems medical went into administration before this issue was identified and it is not known how many affected devices have been supplied.
  • Acción
    Identify, do not use and dispose of affected devices.

Device

  • Modelo / Serial
  • Descripción del producto
    Neonatal and paediatric endotracheal tube clamp/holder. All product codes. All lot numbers. This device assists in securing an endotracheal tube (ETT) in position for neonatal and paediatric patients.
  • Manufacturer

Manufacturer

  • Source
    MHRA