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 Physio Control, Inc || Medtronic Emergency Response Systems, 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
    R1711-540
  • Número del evento
    2012EBC-0008670 ; 2008EBC-0001863
  • Fecha
    2017-11-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=64
  • 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 illustrations of the electrodesreferenced show an incorrect location of the electrodes for a baby, the art printed on the product is incorrect (shows the placement of the pink electrode on the back of the baby), on the other hand the illustration on the outer packaging if is correct (showing the placement of the pink electrode on the baby's chest), this situation could lead to potential serious adverse events on the patients.

Device

PHYSIO CONTROL defibrillator
  • Modelo / Serial
    reduced energy defibrillation electrodes
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    It 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. Recognized method of terminating certain life-threatening arrhythmias, such as ventricular fibrillation and ventricular tachycardia.
  • Manufacturer
    Physio Control, Inc || Medtronic Emergency Response Systems, Inc.

Manufacturer

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