Events

Notificaciones De Seguridad De Campo acerca de Carestation 620, 650 in 650c

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 GE Healthcare.

¿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
  • Fecha
    2017-05-16
  • 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
    Problem 1: between the removable receptacle and the lower circuit of the respiratory circuit on the carestation 600 systems, there is possibility of incomplete sealing. this incomplete seal may lead to a re-inhaling of the patient's gases that overturn the carbon dioxide (co2) absorbing agent, which can lead to an unscheduled rise in the level of inhaled co2 (fico2), which can consequently lead to hypercapnia. problem 2: carestation 600 systems can experience an unexpected transition to a failure state. in this case, the following message appears on the screen: "internal system failure prevents normal operation. use a spare respiratory system. turn off and turn on the station to restart. ".

Device

Carestation 620, 650 in 650c
  • Modelo / Serial
    Carestation 620 A1 (GTIN: 00840682103985); Carestation 650 A1 (GTIN: 00840682103947); Carestation 650c A1 (GTIN: 00840682103954)
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare