Events

Alerte De Sécurité sur Skintact DF32L and DF31L Defibrillation Electrodes for Children

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

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
    2014-12-02
  • Date de publication de l'événement
    2014-12-02
  • 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_20141202b.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: leonhard lang skintact df32l and df31l defibrillation electrodes for children the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning skintact df32l and df31l defibrillation electrodes for children manufactured by leonhard lang gmbh. below are the details of the affected products: 50018 skintact df32l with lot number 30513-0770 59945 skintact df31l with lot numbers 30425-0778 and 30516-0770 during an internal investigation triggered by market feedback, it was discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this potential malfunction can occur with electrodes after a duration of storage of about 2 years or more. the precise cause of this is still under investigation. as this potential malfunction could lead to a lack of, or delay in, providing therapy with potentially serious consequences including death and serious injury, the manufacturer is recalling all lots of these electrodes older than 18 months. other electrodes which show a faultless performance can be used as usual according to the instructions for use. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con477294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2014.

Device

Skintact DF32L and DF31L Defibrillation Electrodes for Children
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Leonhard Lang Skintact DF32L and DF31L Defibrillation Electrodes for Children
  • Manufacturer
    Leonhard Lang GmbH

Manufacturer

Leonhard Lang GmbH