Events

Alerte De Sécurité sur Defibrillation electrode SCHILLER DF87C and Defibrillation electrode SCHILLER DF56C

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
    2016-11-08
  • Date de publication de l'événement
    2016-11-08
  • 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_20161108.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 schiller df87c and defibrillation electrode schiller df56c the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning defibrillation electrode schiller df87c and defibrillation electrode schiller df56c manufactured by leonhard lang. the affected reference number is 0-21-0040 for defibrillation electrode schiller df87c and 2.155065 for defibrillation electrode schiller df56c. during an investigation triggered by customer feedback, it was discovered that the use of the above mentioned defibrillation electrodes with the defibrillator defigard touch 7 may lead to a cable break. this cable break depends on the operating conditions and is caused by the repeated opening and closing of the device bag. investigations have shown that this defect may occur after more than 400 opening and closing cycles at the earliest under certain aggravated mechanical conditions. according to the manufacturer, there is a risk that the required treatment (ecg analysis or delivery of electric shocks) only can be realized after replacement of the electrode. 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 disconnect the connector of current electrodes from the defigard touch 7, keep a second pouch of defibrillation electrodes available in the defigard touch 7 bag and not to preconnect these new electrodes. up to the disposal of spare electrodes the defibrillator defigard touch 7 can be used without restriction using not preconnected electrodes. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-31-october-4-november-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 november 2016.

Device

Defibrillation electrode SCHILLER DF87C and Defibrillation electrode SCHILLER DF56C
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Leonhard Lang Defibrillation electrode SCHILLER DF87C and Defibrillation electrode SCHILLER DF56C
  • Manufacturer
    Leonhard Lang

Manufacturer

Leonhard Lang