Events

Alerta De Seguridad para Anesthesia Machine Fabius GS Premium, Shot, Shot D-M, MRI, plus, plus XL

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Drägerwerk Ag & Co. Kgaa.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    2008EBC-0002363 ; 2008EBC-0002325 ; 2008EBC-0002304 ; 2008EBC-0002362 ; 2008EBC-0002386 ; 2014EBC-0010963
  • Fecha
    2018-03-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=51
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data

Device

Anesthesia Machine Fabius GS Premium, Shot, Shot D-M, MRI, plus, plus XL
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    The FABIUS MRI is an inhalation anesthesia machine that has been designed for use in MRI environments of operating rooms and induction and recovery rooms. It can be used in MRI scanner rooms with 1.5 tesla and 3 tesla magnets for a marginal field strength of 40 mtesla (400 gauss) or less. It can be used with o2, n2o and air (air), supplied by a medical gas piping system or externally mounted gas bottles. FABIUS MRI is equipped with a compact respiratory system that offers fresh gas coupling, PEEP (positive pressure at the end of the breath) and pressure limitation. The equipment offers the following ventilation options: volume controlled ventilation; Pressure controlled ventilation; pressure support (optional); simv / ps (optional), manual ventilation; spontaneous breathing FABIUS MRI is suitable for use in magnetic resonance environments of 1.5 tesla and 3 tesla with a magnetic field of 40 mtesla or less
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa

Manufacturer

Drägerwerk Ag & Co. Kgaa