Events

Alerte De Sécurité sur Maquet Cardiovascular Flow-i Anaesthesia System

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 Cardiovascular.

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
    2016-03-07
  • Date de publication de l'événement
    2016-03-07
  • 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_20160307.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 cardiovascular flow-i anaesthesia system the united states food and drug administration (fda) has issued an alert concerning flow-i anaesthesia system, manufactured by maquet cardiovascular. [model numbers: c20 (for united states), c30 and c40; part numbers: 66 77 200 (united states only), 66 77 300 and 66 77 400; serial numbers: 2743, 2852, 2854, 2855, 2856, 2858] according to the manufacturer, the system is intended for use on neonatal to adult patient populations in hospital environments, except mri environment by healthcare professionals trained in inhalation anesthesia administration. electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (pcbs) that control the sub-systems. the problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. replacement pcbs are now available to correct the issues. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0804-2016&w=03022016&lang=eng posted on 7 march 2016.

Device

Maquet Cardiovascular Flow-i Anaesthesia System

Manufacturer

Maquet Cardiovascular