Events

Alerte De Sécurité sur Maquet FLOW-i Anesthesia System C20, C30, C40

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

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
    2012-07-09
  • Date de publication de l'événement
    2012-07-09
  • 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_20120709.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: maquet flow-i anesthesia system c20, c30, c40 the united states food and drug administration (fda) has issued a class i recall concerning flow-i anesthesia system c20, c30, c40, manufactured by maquet medical systems usa. this action only affected flow-i anesthesia systems distributed between may 2010 and december 2011. in specific c20, c30 and c40 flow-i anesthesia systems, if the man/auto switch was not fully engaged in either an "on" or "off position, but rather was placed in an "in- between position" for more than five seconds, a technical alarm te 613 may have been generated. activation of the technical alarm te 613 causes the system to remain in the original mode selected and does not switch the ventilation mode. to deactivate the technical alarm te 613, the system must be restarted. the corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm310815.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 july 2012.

Device

Maquet FLOW-i Anesthesia System C20, C30, C40
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Maquet FLOW-i Anesthesia System C20, C30, C40
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA