Events

Alerte De Sécurité sur defibrillators cardiolife TEC-8300K series

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Nihon Kohden Corporation.

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
    2012-08-14
  • Date de publication de l'événement
    2012-08-14
  • 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_20120814a.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: nihon kohden defibrillators cardiolife tec-8300k series the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of defibrillators cardiolife tec-8300k series (model no.: tec-8321k, tec-8322k, tec-8332k, tec-8342k and tec-8352k), manufactured by nihon kohden corporation. according to the manufacturer, there is a possibility for a limited number of cardiolife defibrillators tec-8300k series that the battery is not charged when the defibrillator is connected to the ac power. the defibrillator can be used in the battery operating mode until the battery is discharged completely. there is no limitation for the operation of the defibrillator when ac power is connected. 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. posted on 14 august 2012.

Device

defibrillators cardiolife TEC-8300K series
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Nihon Kohden defibrillators cardiolife TEC-8300K series
  • Manufacturer
    Nihon Kohden Corporation

Manufacturer

Nihon Kohden Corporation