Events

Rappel de Inspiration Ventilator System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Event Medical LTD.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72491
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0230-2016
  • Date de mise en oeuvre de l'événement
    2015-10-13
  • Date de publication de l'événement
    2015-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141260
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
  • Action
    eVent Medical sent an Urgent Field Safety Notice dated October 12, 2015, to all affected customers on October 13, 2015, to inform them that eVent Medical is recalling Inspiration Ventilators i Series and LS 12.1 LCD because a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. The letter provides the customers with the problems identified and the actions to be taken. Customers with questions are instructed to call (949) 900-1917, x232.

Device

Inspiration Ventilator System
  • Modèle / numéro de série
    All models manufactured prior to 2015 are affected
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egypt England Estonia Finland Germany Ghana Gibraltar Greece Guatemala Holland Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kenya Korea Kuwait Laos Latin America Lebanon Libya Lithuania Malaysia Mexico Morocco Nepal Netherlands New Zealand Norway Pakistan Palestine Panama Peru Philippines Poland Portugal Russia Saudi Arabia Serbia Singapore South Africa Spain Sri Lanka Sudan Switzerland Syria Taiwan Thailand Turkey UAE Ukraine USA Venezuela Vietnam Yemen Zimbabwe
  • Description du dispositif
    Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
  • Manufacturer
    Event Medical LTD

Manufacturer

Event Medical LTD