Events

Alerta De Seguridad O Notificaciones De Seguridad para Babytherm infant warmers and open infant care units for newborns

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 Draeger 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/2014/041
  • Número del evento
    CON467380
  • Fecha
    2014-10-21
  • Fecha de publicación del evento
    2014-10-21
  • 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/CON467380?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 baby falling out of the device. failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly. draeger sent a field safety notice to its customers in august 2014 but hasn’t had enough replies to know if users have received and acted upon this information.
  • Acción
    Identify affected devices. Ensure users read the important information in the Field Safety Notice (FSN) and follow the instructions (see appendix) to ensure that the inner safety panels are in place and the outer side panels are securely locked into position. If the locking mechanism is not functioning, contact Draeger. Complete the acknowledgement sheet you received with the FSN and return it to Draeger.

Device

Babytherm infant warmers and open infant care units for newborns
  • Modelo / Serial
  • Descripción del producto
    Babytherm infant warmers and open infant care units for newborns. Model numbers: 8004, 8010 and 8000WB. This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.
  • Manufacturer
    Draeger Medical

Manufacturer

Draeger Medical