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.

¿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
    A1712-578
  • Número del evento
    2012EBC-0008670
  • Fecha
    2017-12-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=60
  • 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 power-related failures since the user prepares the device for initial download or during its use within the first year of distribution, failures may include unexpected power on and off, device lockout or failure to turn on or off, such failures are the as a result of a debris from the manufacturing process located under a component mounted on the power circuit board (pcba) assembly, any of these faults could result in failure to deliver the therapy to the patient and serious injury or death, leading to that potentially serious adverse events occur on patients.

Device

PHYSIO CONTROL defibrillator
  • Modelo / Serial
    LIFEPAK 20E
  • Descripción del producto
    It provides stimulation to the heart for the automatic treatment of ventricular arrhythmias that endanger the life of the patient and when they exhibit symptoms of sudden cardiac arrest.
  • Manufacturer
    Physio Control, Inc

Manufacturer

Physio Control, Inc
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NIDFSINVIMA