Events

Alerta De Seguridad para Intracranial Monitoring System

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 Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integra Lifesciences Limited (Ireland).

¿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
    I1505-192
  • Número del evento
    2010DM-0006272
  • Fecha
    2015-05-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • 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 there is a possibility of failures in the system of sound alarms due to the malfunctioning of the speaker, leading to the occurrence of possible adverse events on the patients.

Device

Intracranial Monitoring System
  • Modelo / Serial
    Licox and Camino, reference CAM02 and LCX02 / LCX02R
  • Descripción del producto
    The integrated intracranial neuromonitoring system is indicated to measure and record pressure, temperature and / or intracranial oxygen of patients that require this type of monitoring in the parenchyma or in the subacranial space for administration of severe cerebral lesions and in case of cerebral hypertension and in extracranial medical conditions such as failurehepatic or cardiac bypass surgery. The transducer catheter of the system is indicated to obtain the depression, temperature or o2 measurement inside directly from the inside of the patient's skull or through a cerebrospinal fluid adrenaje connector and is designed to be specifically connected to the intracranial monitor through the preamplification cable of the system. The instruments of the system are specific and indispensable for the implantation or removal of the transducer catheter because they have been specifically designed for the system. The use of other instruments can jeopardize the integrity and performance of the system as well as the safety and life of the patient.
  • Manufacturer
    Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integra Lifesciences Limited (Ireland)

Manufacturer

Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integr...