Events

Alerta De Seguridad para CDI™ Blood Parameter Monitoring System 500

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

¿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
    2012-01-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126a.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: terumo cdi™ blood parameter monitoring system 500 medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice on the use of cdi™ blood parameter monitoring system 500. the manufacturer identified that contact between the power cables and the sharp edge of the chassis can potentially damage the cables’ insulation. this could result in an electrical short, which could further create sparking, fire, smoke, shock or monitor failure. there have been no reports of occurrence of this issue or patient injury as a result of this issue. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

CDI™ Blood Parameter Monitoring System 500

Manufacturer

Terumo Cardiovascular Systems Corporation