Events

Alerte De Sécurité sur Corpatch Easy Pediatric

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
    2015-05-11
  • Date de publication de l'événement
    2015-05-11
  • 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_20150511a.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 corpatch easy pediatric australian therapeutic goods administration (tga) posted a medical device safety alert concerning corpatch easy pediatric (defibrillator electrodes), manufactured by leonhard lang gmbh. the affected product code is cp-5120.2 with lot numbers 30708-0777, 30822-0778, 31009-0773, 31121-0774, 40107-0771, 40213-0774, 40222-0773, 40320-0770, 40321-0770, 40324-0773, 40522-0779, 40704-0776, 40808-0773, 40923-0776, 41021-0778 the manufacturer’s internal investigation showed that during the use of these defibrillation electrodes, a possibility for arcing and a resulting malfunction exists. this malfunction can occur with defibrillation electrodes that are older than 2 years. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. the precise cause for this is still under investigation. product replacement is on-going. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00388-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2015.

Device

Corpatch Easy Pediatric
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Leonhard Lang Corpatch Easy Pediatric
  • Manufacturer
    Leonhard Lang GmbH

Manufacturer

Leonhard Lang GmbH