Events

Notificaciones De Seguridad De Campo acerca de G5/HAMILTON-S1 ventilators

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 Hamilton Medical AG.

¿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
    2016-03-07
  • 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
    Investigations have shown that after performing the suctioning maneuver, including disconnecting the patient, suctioning, and reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator- selected mode may be applied; this situation can occur independent from the selected patient group (neonate, pediatric, or adult). this situation may occur in the hamilton-g5 and hamilton-s1 if the ventilation mode changes during the pre-oxygenation phase. after the suctioning maneuver is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. .

Device

G5/HAMILTON-S1 ventilators
  • Modelo / Serial
    All HAMILTON-G5/HAMILTON-S1 ventilators with software versions v2.41, v2.42 and v2.50
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG