Events

Alerta De Seguridad para Freedom 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.

¿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
    2012-01-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120104a.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: syncardia freedom driver system the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers regarding the freedom driver system manufactured by syncardia systems, inc. according to the manufacturer, a freedom driver supporting a patient in the united states exhibited intermittent low cardiac output alarms as a result of instances of elevated systolic blood pressure readings above 160mmhg. while all distributed freedom drivers are within specifications, some can support a higher level of transient instances of hypertension than others. the driver that is the subject of the event was less tolerant to these elevated pressures, resulting in the low co alarms. syncardia is replacing freedom drivers that are less tolerant of these types of events with drivers that are more tolerant of these types of elevated systolic pressures. 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 products, please stop using them and contact your supplier for necessary actions.

Device

Freedom Driver System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SynCardia Freedom Driver System
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems