Events

Alerta De Seguridad para PHYSIO CONTROL defibrillator

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 Medtronic Emergency Response Systems, Inc. || Physio-Control, 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
    A1702-38
  • Número del evento
    2008EBC-0001863 ; 2012EBC-0008670
  • Fecha
    2017-02-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 received 34 reports where customers reported that when trying to use the equipment referenced this has stopped working unexpectedly due to an intermittent connection between the battery and its electrical contactors, the equipment in this situation may not be able to deliver the necessary discharge during a attempt to resuscitate, leading to the occurrence of serious events about patients.

Device

PHYSIO CONTROL defibrillator
  • Modelo / Serial
    LIFEPAK 1000, specific serials.
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Recognized method of terminating certain life-threatening arrhythmias, such as ventricular fibrillation and symptomatic tachycardia-ventricular. Provides stimulation to the heart for the automatic treatment of ventricular arrhythmias that endanger the patient's life and when they exhibit symptoms of sudden cardiac arrest.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc. || Physio-Control, Inc

Manufacturer

Medtronic Emergency Response Systems, Inc. || Physio-Control, Inc
  • Source
    NIDFSINVIMA