Events

Alerte De Sécurité sur Defibrillation Electrode SKINTACT DF29N

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.

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
    2016-09-20
  • Date de publication de l'événement
    2016-09-20
  • 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_20160920.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 defibrillation electrode skintact df29n the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning defibrillation electrode skintact df29n manufactured by leonhard lang. the affected article number is 50028. during an investigation triggered by customer feedback, the manufacturer discovered that it can be aggravated to connect these defibrillation electrodes with the defibrillator welch allyn aed 10. as a consequence, it may happen that the user does not connect the electrodes with the defibrillator in an emergency situation. according to the manufacturer, there is a risk that the affected electrodes will be connected with the defibrillator only with delay or not at all. this may cause a situation in which a patient, who is in a life-threatening condition and requires a defibrillation shock, cannot be treated in good time. the manufacturer advises users to quarantine and destroy all unused affected products. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-12-16-september-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 september 2016.

Device

Defibrillation Electrode SKINTACT DF29N
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Leonhard Lang Defibrillation Electrode SKINTACT DF29N
  • Manufacturer
    Leonhard Lang

Manufacturer

Leonhard Lang