Events

Alerta De Seguridad para Medical Bed

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 Hill Rom SAS.

¿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
    I1603-103
  • Número del evento
    2014DM-0011799
  • Fecha
    2016-03-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=152
  • 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 has detected that by placing a load on the rear section of the bed, the plane may be noisy or lose its functionality due to premature mechanical wear of the actuator, which does not affect the emergency rpc function, but could lead to potentially adverse events. about the patients.

Device

Medical Bed
  • Modelo / Serial
    AVANTGUARD 1600, serial CS160A0005XXX up to PRS160A0005XXX, manufactured between June 2009 and December 2015.
  • Descripción del producto
    The HILL-ROM 900 and AVANTGUARD 1600 medical beds have been designed for general care, surgery, intensive and post-operative or obstetric care, and allow general or intensive care, as well as using the advanced techniques used in specialized units.
  • Manufacturer
    Hill Rom SAS

Manufacturer

Hill Rom SAS