Events

Alerta De Seguridad O Notificaciones De Seguridad para Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS

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 Physio-Control.

¿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
  • Fecha
    2016-10-13
  • Fecha de publicación del evento
    2016-10-13
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/automatic-external-defibrillator-aed-lifepak-cr-plus-and-lifepak-express-risk-of-failure-to-deliver-a-shock
  • 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
    LIFEPAK CR Plus AEDs or LIFEPAK EXPRESS AEDs may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened. The problem is due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock.
  • Causa
    Manufactured by physio-control – risk of delay to defibrillation due to an intermittent component failure. specific serial numbers are affected.
  • Acción
    Ensure that all those responsible for the AED follow the instructions in the manufacturer’s Field Safety Notice FSN To check if your AED is affected call Physio-Control customer support or visit their website and go to ‘Search Affected Devices’ and enter the serial numbers. If the AED is faulty, remove the unit from service and contact Physio-Control to arrange for it to be corrected. If you have already acted on this FSN, no further action is required.

Device

Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS
  • Modelo / Serial
  • Descripción del producto
    The AED can be found in hospitals and in public places (eg railway stations, village halls and supermarkets).
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Dirección del fabricante
    Physio-Control Operations, Netherlands Telephone: 0808 258 0094Email: RS.EMEArecall@physio-control.com
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    MHRA