Events

Notificaciones De Seguridad De Campo acerca de LIFEPAK CR® Plus AED and LIFEPAK EXPRESS®

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia 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
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Physio-control has encountered a problem where aifs lifepak cr plus or lifepak express do not start sounding when the on / off button is pressed when the cover is opened due to an internal component (pole switches), however, it may occasionally remain fixed in the closed position. physio-control has found that there are currently 25,178 devices in circulation, of which about 9,600 have this defective component. such a defibrillator will not trigger shock, so potential treatment will not be performed and the patient will not be resuscitated. all reports we received from customers were provided at initial preparation and when testing the device. to date, we have not received reports of patient-related events.

Device

LIFEPAK CR® Plus AED and LIFEPAK EXPRESS®

Manufacturer

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