Events

Alerte De Sécurité sur Freedom 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.

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
    2012-01-04
  • 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_20120104a.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
    Field safety notice: syncardia freedom driver system the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers regarding the freedom driver system manufactured by syncardia systems, inc. according to the manufacturer, a freedom driver supporting a patient in the united states exhibited intermittent low cardiac output alarms as a result of instances of elevated systolic blood pressure readings above 160mmhg. while all distributed freedom drivers are within specifications, some can support a higher level of transient instances of hypertension than others. the driver that is the subject of the event was less tolerant to these elevated pressures, resulting in the low co alarms. syncardia is replacing freedom drivers that are less tolerant of these types of events with drivers that are more tolerant of these types of elevated systolic pressures. 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 products, please stop using them and contact your supplier for necessary actions.

Device

Freedom Driver System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SynCardia Freedom Driver System
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems