Events

Alerta De Seguridad O Notificaciones De Seguridad para ConchaTherm Neptune heated humidifiers

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 Teleflex.

¿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/2012/068
  • Número del evento
    CON185606
  • Fecha
    2012-09-25
  • Fecha de publicación del evento
    2012-09-25
  • 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/CON185606?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
    Potential for failure of the speaker. if the speaker fails, no alarm will sound in the event of a device failure, which could cause a delay in patient treatment. the manufacturer published a field safety notice (fsn), in june 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon. although the speaker failure will result in no alarm sounding if there is a problem, the humidifier will continue to detect any abnormalities and take appropriate action.
  • Acción
    Locate and identify all affected devices using the list of serial numbers in the manufacturer’s FSN. Check the speaker by following the instructions in the manufacturer’s FSN. Return the acknowledgement form to Teleflex. If faulty speakers are found, contact Teleflex immediately to request replacement speakers as a priority. For future use, be aware that if the humidifier makes neither an audible alert nor alarm as part of the self-check on startup, there may be a fault with the speaker.

Device

ConchaTherm Neptune heated humidifiers
  • Modelo / Serial
  • Descripción del producto
    ConchaTherm Neptune heated humidifiers. Product codes: 425–00, 425–10 and 425–30. Specific serial numbers. This heated humidification system is designed to heat and humidify respiratory gases delivered to adult and paediatric patients.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex