Events

Alerte De Sécurité sur Intracranial Monitoring System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integra Lifesciences Limited (Ireland).

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1505-192
  • Numéro de l'événement
    2010DM-0006272
  • Date
    2015-05-12
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Licox and Camino, reference CAM02 and LCX02 / LCX02R
  • Description du dispositif
    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...