Events

Alerta De Seguridad para Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Physio-Control Inc..

¿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
    2016-02-16
  • Fecha de publicación del evento
    2016-02-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160216.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
    Medical device safety alert: physio-control adult-edge electrode with quik-combo connector and redi-pak preconnect the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning adult-edge electrode with quik-combo connector and redi-pak preconnect manufactured by physio-control inc. [catalogue number: 11996-000017; min number: 3202674-005; lot numbers: 516907, 519815, 519816]. the manufacturer conducted a voluntary recall of the abovementioned product due to a low-level potential for damage to the wire insulation during the manufacturing process of these specific lots. the defibrillation electrodes used in conjunction with certain physio-control lifepakr products. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician bum. the manufacturer advises customers to quarantine the affected products and return them to the manufacturer. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 february 2016.

Device

Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
  • Manufacturer
    Physio-Control Inc.

Manufacturer

Physio-Control Inc.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH