Events

Alerte De Sécurité sur Companion External Battery

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
    2013-01-14
  • Date de publication de l'événement
    2013-01-10
  • 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_20130114.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 companion external battery the food and drugs administration (fda), united states posted a medical device safety alert concerning companion external battery, part number: 293001-001, manufactured by syncardia systems, inc. according to the fda, the companion external battery is a component of the companion 2 driver system and the companion driver system. both driver systems, with the temporary total artificial heart are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. the manufacturer is recalling the companion external batteries used with the companion 2 driver system because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm? action=select&recall_number=z-0620-2013&w=01092013&lang=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 january 2013.

Device

Companion External Battery
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SynCardia Companion External Battery
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems