Events

Notificaciones De Seguridad De Campo acerca de EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland 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
    Field Safety Notice
  • Número del evento
    SN2012(13)
  • Fecha
    2012-08-24
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ems-medical-neonatal-paediatric-endotracheal-tube-clamp-holder&id=d27df825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    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 over one year ago before this issue was identified.  the imb included a copy of mda/2012/049 in the july monthly mailing. at that time it was not known if there were any affected devices on the irish market. the imb now believe that some devices were supplied to irish customers.
  • Acción
    The IMB advises healthcare professionals/users to:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify, do not use and dispose of affected devices.  3. Inform the IMB if you have affected devices at your institution.

Device

EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • Modelo / Serial
  • Descripción del producto
    EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    HPRA