Events

Alerta De Seguridad para Pedi-Padz Reduced Energy Electrode, Model # 8900-0401

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Zoll Medical 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
    2012-02-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120209.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
    Field safety notice: zoll pedi-padz reduced energy electrode, model # 8900-0401 health canada, has issued a type ii recall on pedi-padz reduced energy electrode, model # 8900-0401, manufactured by zoll medical corporation. according to the manufacturer, the products are being recalled because a problem was identified through the supplier’s internal quality system on a production lot. the issue is the lack of an adequate silicone seal around the periphery of the attenuator enclosure which houses an in-line series of resistors designed to restrict the level of energy being transmitted to a pediatric recipient during defibrillation. the affected lot numbers were from 0511 to 4511. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Zoll Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation