Events

Alerta De Seguridad para Companion 2 Driver System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por SynCardia Systems, 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
    2012-01-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120110.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: syncardia companion 2 driver system the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning syncardia companion 2 driver system. investigation by the device manufacturer, syncardia systems, inc., of a reported incident revealed that the internal power cable between the main board and power management board had an intermittent connection which caused the companion 2 driver to alarm and lose power. the intermittence was caused by an improper crimp by the supplier on the power cable assembly leads. the problem may result in loss of cardiac output resulting in decreased perfusion of the organs (brain, liver, kidneys etc.). if a patient is not switched to the backup driver in a timely manner, long range health consequences such as organ dysfunction or failure may be resulted. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Companion 2 Driver System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SynCardia Companion 2 Driver System
  • Manufacturer
    SynCardia Systems, Inc.

Manufacturer

SynCardia Systems, Inc.