Events

Alerta De Seguridad para unkown device

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 Welch Allyn Protocol Inc. || Welch Allyn Inc.

¿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
    I1402-60
  • Número del evento
    2009EBC-0003199
  • Fecha
    2014-02-10
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=210
  • 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
    It is affirmed by the manufacturer that the welchallyn parent company will end with the manufacture and sale of the mentioned references after december 2014, in particular propaq cs with the option of co2 was suspended since january 24, 2014, however, informs that it will continue to provide support and technical service for up to five (5) more years or until the spare parts and accessories are exhausted.

Device

unkown device
  • Modelo / Serial
    ACUITY CENTRAL, MICROPAQ, MOBILE ACUITY LT, PROPAQ CS, COMMUNICATION SERVER (WACS), PROPAQ || LT and 1500
  • Descripción del producto
    Electronic device that captures and amplifies the electrical activity of the heart through electrodes placed in the 4 extremities and in 6 positions in the chest, measures the average arterial pressure, the pulse, the oxygen saturation and the temperature.
  • Manufacturer
    Welch Allyn Protocol Inc. || Welch Allyn Inc

Manufacturer

Welch Allyn Protocol Inc. || Welch Allyn Inc