Events

Alerta De Seguridad para Powerheart G5 Automated External Defibrillator (AED) Electrode Connector

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Cardiac Science Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-02-05
  • Fecha de publicación del evento
    2014-02-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140205.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cardiac Science Powerheart G5 Automated External Defibrillator (AED) Electrode Connector
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation