Events

Alerte De Sécurité sur Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators

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
    2014-12-08
  • Date de publication de l'événement
    2014-12-08
  • 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_20141208a.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: ge healthcare defibrillation electrode for children (leonhard lang) used with ge defibrillators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning defibrillation electrodes for children manufactured by leonhard lang. the defibrillation electrodes are for use with defibrillators manufactured by ge healthcare. the affected product codes are 2059144-001 and 2059144-005 (df69, 50461) and the affected lot numbers are 21003-0770, 21113-0777 and 21220-0771. following an internal investigation triggered by reports in the field, the manufacturer identified that during the use of these defibrillation electrodes, a possibility for arcing and a resulting malfunction exists. this could lead to delay in therapy or no therapy at all. the inability to defibrillate or a delay in doing so can lead to the death or severe injury of the patient. according to the manufacturer, this potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more. the manufacturer advises customers to quarantine the affected lot numbers and return them for replacement. for details, please refer to the following link: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2014-rn-01266-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 december 2014.

Device

Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
  • Manufacturer
    Leonhard Lang

Manufacturer

Leonhard Lang