Events

Alerta De Seguridad para infinity acute care system workstation critical care Drager

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 Draeger Medical Systems, Inc. || 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
  • ID del evento
    I1611-534
  • Número del evento
    2009EBC-0004116
  • Fecha
    2016-11-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=112
  • 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
  • Causa
    The manufacturer informs about the possibility that the expected alarms will not occur in the central display module (cockpit) and in the m540 (in none will the visual alarms be affected), likewise, the appropriate audible and visual alarms will normally be present in the ics. which could lead to the occurrence of potentially adverse events on the patients.

Device

infinity acute care system workstation critical care Drager
  • Modelo / Serial
    IACS with software version VG5.0
  • Descripción del producto
    This equipment allows the ventilation of adult and pediatric patients. It allows the selection of mandatory ventilation modes, ventilation modes, assisted to spontaneous breathing and respiratory monitoring, with monitoring and control screens for the INFINITY acute care system, which is carried out through the SMARTCARE software program specially designed for the automation of therapeutic measures.
  • Manufacturer
    Draeger Medical Systems, Inc. || Drägerwerk Ag & Co. Kgaa

Manufacturer

Draeger Medical Systems, Inc. || Drägerwerk Ag & Co. Kgaa