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
    2018-02-28
  • Date de publication de l'événement
    2018-02-28
  • 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_20180228a.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: syncardia freedom driver system the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning syncardia freedom driver system used with the syncardia temporary total artificial heart (tah-t) [model number: 595000-001], manufactured by syncardia systems. the manufacturer is making changes to the manuals and labeling of the freedom driver system model no. 595000-001 that will strengthen existing warnings for users with regard to freedom driver drops, rough handling and exposure to liquid/debris. according to the manufacturer, the updates to the warnings in the freedom driver system manuals and labeling will enhance the safe use of the freedom driver system. if the freedom driver is dropped, exposed to liquid/debris or subjected to rough handling, it may sustain damage that will not allow it to provide life-sustaining functions as designed. serious injury or death could occur because of the failure of a freedom driver. in the event that a patient’s freedom driver is dropped, subjected to rough handling or exposed to liquid/debris, the patient must switch to the backup freedom driver. the manufacturer is conducting a voluntary field safety corrective action to reinforce these changes by informing freedom driver customers of the changes and ensuring that the clinical staff and patients review the changes and that the patients are trained on the new labeling. for details, please refer to the following mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-19-to-23-february-2018 according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 february 2018.

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