Events

Alerte De Sécurité sur Companion 2 Driver 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 SynCardia Systems, Inc..

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
    2012-01-10
  • 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_20120110.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
    Mhra field safety notice: syncardia companion 2 driver system the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning syncardia companion 2 driver system. investigation by the device manufacturer, syncardia systems, inc., of a reported incident revealed that the internal power cable between the main board and power management board had an intermittent connection which caused the companion 2 driver to alarm and lose power. the intermittence was caused by an improper crimp by the supplier on the power cable assembly leads. the problem may result in loss of cardiac output resulting in decreased perfusion of the organs (brain, liver, kidneys etc.). if a patient is not switched to the backup driver in a timely manner, long range health consequences such as organ dysfunction or failure may be resulted. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Companion 2 Driver System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SynCardia Companion 2 Driver System
  • Manufacturer
    SynCardia Systems, Inc.

Manufacturer

SynCardia Systems, Inc.