Events

Alerta De Seguridad para Cardiocall event recorder

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 Spacelabs Medical 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
    I1511-519
  • Número del evento
    2008DM-0003080 sonido doble, seguido de un timbre continuo que solo se
  • Fecha
    2015-11-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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 identified that the equipment can emit undetiene when removing the battery, leading to possible delays in the care of patients.

Device

Cardiocall event recorder
  • Modelo / Serial
    Models VS20, VS20x4, ST80 and ST80x4 and PCBA part number 670-1670-00, dispatched between December 23 || of 2014 and August 19, 2015
  • Descripción del producto
    This equipment has been designed and provided specifically for the monitoring of electrocardiograms activated by the patient. Indicated to record the electrocardiogram when a patient experiences intermittent transient symptoms such as dizziness, palpitations or shortness of breath, and this is able to activate the recorder in these sessions. The electrocardiogram is stored in memory.
  • Manufacturer
    Spacelabs Medical Inc.

Manufacturer

Spacelabs Medical Inc.