Events

Alerta De Seguridad para EV1000 Databox and Monitor

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

¿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
    2016-05-30
  • Fecha de publicación del evento
    2016-05-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160530.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: edwards lifesciences ev1000 databox and monitor medical device manufacturer, edwards lifesciences, has issued a medical device safety alert concerning its ev1000 databox and monitor [model number: ev1000a]. the safety alert reinforces the proper set up of the external power supply according to the equipment operator manual. the manufacturer has recently been notified about an electrical fire that initiated at the power supply of one of the ev1000a system due to noncompliant system installation configuration which caused fluid ingress to the power supply. the manufacturer is not removing product from commercial distribution. the manufacturer is informing all affected users with ev1000a systems to confirm compliance of installation configuration against the current requirements documented in the operator’s manual section ev1000 power adapter mounting bracket. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 may 2016.

Device

EV1000 Databox and Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Edwards Lifesciences EV1000 Databox and Monitor
  • Manufacturer
    Edwards Lifesciences

Manufacturer

Edwards Lifesciences