Events

Notificaciones De Seguridad De Campo acerca de Oxylog 3000, Oxylog 3000 plus

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 Drägerwerk AG & Co. KGaA.

¿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
    In december 2015, we notified you of an error we noticed in the market for oxylog 3000 family products, where the loss of contact of one of the control buttons triggers an error message (formerly known as a "potentiometer off"). in these cases, acoustic and optical signals are triggered and the respiratory release pressure and ventilation function are interrupted. no injuries were reported in any of these cases. our investigations have shown that fault conditions are triggered by the oxide layer in the potentiometer. oxide layers can form over time when several factors are present, e.G. if you rarely move the buttons or not at all. the proven solution is repeated knob rotation to remove the oxide layer. this recommendation was described in a previous safety notice.

Device

Oxylog 3000, Oxylog 3000 plus

Manufacturer

Drägerwerk AG & Co. KGaA