Events

Notificaciones De Seguridad De Campo acerca de LIFEPAK® CR Plus Automatic External Defibrillator

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland 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
    Field Safety Notice
  • Número del evento
    SN2010(08)
  • Fecha
    2010-07-19
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/lifepak-cr-plus-automatic-external-defibrillator&id=0b8bf825-9782-6eee-9b55-ff00008c97d0
  • 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
    The potential for the lifepak® cr plus to not deliver therapy still exists due to a device upgrade that has not been completed on all of the affected devices on the irish market.
  • Acción
    1. Ensure the appropriate personnel are made aware of this notice.  2. Identify affected LIFEPAK® CR Plus defibrillators (Please see Attachment 1 for affected serial numbers)  3. Confirm if defibrillators have been upgraded by Oxygen Care (repair and servicing company for Physio-Control products in Ireland) in relation to this issue.  4. If any of the affected defibrillators has not been upgraded, immediately contact Medtronic or Oxygen Care (see contact details below) to arrange the correction of the defibrillator, and follow the recommendations listed in the FSN.  5. Perform regular monthly inspection as per LIFEPAK® CR Plus operating instructions AND verify that the voice prompt is heard at power on.  6. If, at any time, the voice prompt is not heard or any other indicator displays bar “OK”, immediately contact Medtronic.

Device

LIFEPAK® CR Plus Automatic External Defibrillator
  • Modelo / Serial
  • Descripción del producto
    LIFEPAK® CR Plus Automatic External Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HPRA