Events

Alerta De Seguridad para Alaris PC unit

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

¿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
    2014-01-07
  • Fecha de publicación del evento
    2014-01-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140107.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: carefusion alaris pc unit the united states food and drug administration (fda) posted a medical device safety alert concerning the alaris pc unit model 8000 and 8015 with alaris patient controlled analgesia (pca) module model 8120 and auto id barcode scanner model 8600 manufactured by carefusion. the alaris pc unit is the central programming, monitoring and power supply component for the alaris system. the alaris pca pump is one of the modules offer under the alaris system. the auto id is a barcode scanner. according to the manufacturer, the alaris pc unit (model 8000 and 8015) was recalled because the alaris pc unit will produce an audible alarm and display a system error message. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0534-2014&w=01012014&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 january2014.

Device

Alaris PC unit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Carefusion Alaris PC unit
  • Manufacturer
    CareFusion

Manufacturer

CareFusion