Events

Notificaciones De Seguridad De Campo acerca de Nellcor Durasensor® (DS-100A) sensors Product Code: DS-100A

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Tyco Healthcare group LP.

¿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
    SN2011(01)
  • Fecha
    2011-01-21
  • 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=/counterfeit-covidien-nellcor-spo2-durasensor-(ds-100a)-sensors&id=1589f825-9782-6eee-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 supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB advises that:  • All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit identify, locate and quarantine all product to ensure it will not be used.  • If you identify that you have product that is counterfeit you should submit the information detailed in Appendix I to theHPRA (enforcement@hpra.ie). On receipt of this information the IMB will contact you to advise what further course of action is required.

Device

Nellcor Durasensor® (DS-100A) sensors Product Code: DS-100A
  • Modelo / Serial
  • Descripción del producto
    Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors
  • Manufacturer
    Tyco Healthcare group LP

Manufacturer

Tyco Healthcare group LP
  • Source
    HPRA