Events

Alerta De Seguridad para surgical table system

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 Maquet Gmbh & Co. Kg || Maquet Sas || Maquet (Suzhou) Co., Ltd.

¿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
    I1512-596
  • Número del evento
    2014DM-0012045
  • Fecha
    2015-12-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • 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 states that it has detected that the extension can be removed from the table when it is subjected to a collision, if it is not positioned according to the instructions for use, leading to the occurrence of potentially adverse events on the patient.

Device

surgical table system
  • Modelo / Serial
    MAGNUS, concerning the extension device reference 1180.19X0
  • Descripción del producto
    The surgical table system is used for the placement and positioning of patients for surgical treatment immediately before, during and after the operative phase. The surgical table system is accompanied by a set of accessories that allows it to be configured to adapt to the different requirements of a wide range of surgical treatments.
  • Manufacturer
    Maquet Gmbh & Co. Kg || Maquet Sas || Maquet (Suzhou) Co., Ltd

Manufacturer

Maquet Gmbh & Co. Kg || Maquet Sas || Maquet (Suzhou) Co., Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NIDFSINVIMA