Events

Alerte De Sécurité sur Powerheart G5 Automated External Defibrillator (AED) Electrode Connector

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Cardiac Science Corporation.

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
    2014-02-05
  • Date de publication de l'événement
    2014-02-05
  • 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_20140205.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
    Mhra field safety notice: cardiac science powerheart g5 automated external defibrillator (aed) electrode connector the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning powerheart g5 automated external defibrillator (aed) electrode connector manufactured by cardiac science corporation (csc). the aeds, shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. the affected models include powerheart g5s and g5a aeds. according to csc, some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognize that pads have been placed on the patient during a rescue attempt. if the issue occurs, the aed may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. this could lead to serious adverse health events or death. csc will be arranging for repair of affected devices for users. according to the local supplier, pacific medical systems, the affected devices were not distributed in hong kong. for details, please refer to the following link: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con370003.Pdf if you are in possession of the affected product, please contact your supplier or pacific medical systems for necessary actions. posted on 05 february 2014.

Device

Powerheart G5 Automated External Defibrillator (AED) Electrode Connector
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cardiac Science Powerheart G5 Automated External Defibrillator (AED) Electrode Connector
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation