Notificaciones De Seguridad De Campo acerca de Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por YSM Medical & Rehabilitation Equipment Ltd.

¿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
    SN2009(12)
  • Fecha
    2009-12-10
  • País del evento
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
  • 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
    Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
  • Acción
    Advice for Retailers and Wholesalers  (1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.  (2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  (3) Ensure the appropriate personnel are made aware of this notice.  Advice for Healthcare Institutions / Consumers  (1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.  (2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.  (3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.  (4) Ensure the appropriate personnel are made aware of this notice.

Device