Events

Alerta De Seguridad O Notificaciones De Seguridad para IW900-series infant warmers

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 Fisher and Paykel Healthcare.

¿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/2014/048
  • Número del evento
    CON491150
  • Fecha
    2014-12-18
  • Fecha de publicación del evento
    2014-12-18
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON491150?tabName=allTabs
  • 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 serious injury to the infant in the warmer the heater head may partially detach due to a manufacturing fault where the nut securing the heater head may break. fisher and paykel healthcare issued a field safety notice (fsn) dated 13 november and provided replacement nuts to customers affected but has not had enough replies to know that users have received and acted on this.
  • Acción
    Follow the advice in the FSN to identify the infant warmers and any spare parts that may be affected. Replace affected nuts using the nuts supplied with the FSN. Contact Fisher & Paykel Healthcare if you are not sure about affected devices or how to replace the nut. Complete the FSN response form and return it to Fisher and Paykel Healthcare.

Device

IW900-series infant warmers
  • Modelo / Serial
  • Descripción del producto
    IW900-series infant warmers. Specific model and lot numbers are affected.
  • Manufacturer
    Fisher and Paykel Healthcare

Manufacturer

Fisher and Paykel Healthcare