Events

Alerte De Sécurité sur Inspiration LS, and i Series Ventilator Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par eVent Medical.

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
  • Date
    2015-10-20
  • Date de publication de l'événement
    2015-10-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151020.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: event medical inspiration ls, and i series ventilator systems the medicines and healthcare products regulatory agency (mhra) of united kingdom has posted a medical device safety alert concerning inspiration ls, and i series ventilator systems manufactured by event medical. all inspiration ventilators i series and ls 12.1" lcd built before 21 january 2015 are affected. according to the manufacturer, a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. this failure could result in death or serious injury to a patient. the manufacturer advises users to discontinue use of the affected ventilators immediately until correction is completed. the manufacturer also advises affected users to take the following actions:- for users who have the ls, 5i, or 7i inspiration ventilator system models subject to this field safety notice, the manufacturer has identified a correction to this issue which requires removal of the potentially faulty component from the power board. for users who have older models that are not the ls, 5i, or 7i model, these ventilators should be taken out of service. these models are no longer supported with spare parts or software versions and should be retired. for details, please refer to the mhra website:https://mhra.Filecamp.Com/public/file/2bog-sl9dth3p if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 october 2015.

Device

Inspiration LS, and i Series Ventilator Systems
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: eVent Medical Inspiration LS, and i Series Ventilator Systems
  • Manufacturer
    eVent Medical

Manufacturer

eVent Medical