Events

Alerte De Sécurité sur EV1000NI clinical platform

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 Edwards Lifesciences Llc || Edwards Lifesciences Ag.

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
    R1712-575
  • Numéro de l'événement
    2016EBC-0014585
  • Date
    2017-12-29
  • 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=60
  • 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 informs that it has detected that the devices are susceptible to appear an error message "hrs out of range", when they are six months after the date of manufacture, because said situation could lead to possible delays in the procedures and events. adverse on patients.

Device

EV1000NI clinical platform
  • Modèle / numéro de série
    HRS sensors, reference EVHRS
  • Description du dispositif
    The NI (non-invasive) clinical platform EV1000NI and its accessories are a monitoring system that shows hemodynamic parameters derived from continuous noninvasive measurements of blood pressure waves. The EV1000NI system helps physicians in the assessment of the patient's physiological status and supports the clinical decision related to hemodynamic optimization. The EV1000NI clinical platform is indicated for use in patients over 18 years of age in whom the balance between cardiac function, fluid status and vascular resistance requires continuous evaluation. Additionally EV1000NI is indicated for use in patients with co-morbidities for which hemodynamic optimization and invasive measures are difficult. EV1000NI measures non-invasive blood pressure and the associated hemodynamic parameters.
  • Manufacturer
    Edwards Lifesciences Llc || Edwards Lifesciences Ag

Manufacturer

Edwards Lifesciences Llc || Edwards Lifesciences Ag