Events

Alerta De Seguridad para Companion External Battery

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
    2013-01-14
  • Fecha de publicación del evento
    2013-01-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130114.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: syncardia companion external battery the food and drugs administration (fda), united states posted a medical device safety alert concerning companion external battery, part number: 293001-001, manufactured by syncardia systems, inc. according to the fda, the companion external battery is a component of the companion 2 driver system and the companion driver system. both driver systems, with the temporary total artificial heart are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. the manufacturer is recalling the companion external batteries used with the companion 2 driver system because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning. 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-0620-2013&w=01092013&lang=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 january 2013.

Device

Companion External Battery
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SynCardia Companion External Battery
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems