Events

Alerte De Sécurité sur Defibrillation electrodes

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
    2016-02-11
  • Date de publication de l'événement
    2016-02-11
  • 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_20160212a.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 electrodes medical device manufacturer, leonhard lang, has issued a medical device safety alert concerning its defibrillation electrodes. the affected models are: 50017 – skintact (df30l), 50018 – skintact (df32l), mindray mr-61 (df39g), 50611 – mindray mr-61 (df74gc), 50617 – cariaid (df73gc), 50626 – weinmann pediatric (df71g), 50636 – osatu pediatric ksa 0501 b (df75g), 50645 – skintact (df72g), 59945 – skintact (df31l) and 59966 – skintact (df35l). in the course of in-house shelf-life tests, performed in addition to accelerated aging tests, the manufacturer has identified the potential risk of sparkover, which may result in a malfunction of these defibrillation electrodes. the potential malfunction can occur with these electrodes after a duration of storage of about 28 months or more. all electrodes with a duration of storage of 28 months or less show a faultless performance and can be used as usual according to the instructions for use. according to the manufacturer, there is a risk that the affected electrodes will exhibit this malfunction before reaching the indicated expiration date. 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 precise cause for this is still under investigation. the manufacturer requests users to immediately stop using and destroy the affected products. product recall is on-going. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 february 2016.

Device

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

Manufacturer

Leonhard Lang