Events

Retiro De Equipo (Recall) de Edwards Lifesciences Heart Reference Sensor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00503-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-06-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00503-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    A component of the clearsight system can be damaged if not handled properly. the heart reference sensor (model number evhrs) compensates for pressure differences between the finger cuff and the heart. the finger component of the evhrs may be damaged if subjected to moderate to significant surface impact.
  • Acción
    Edwards Lifesciences is providing work around instructions to assist end users in determining whether the Heart Reference Sensor has been damaged. An insert, included with the recall letter, will be provided with all new EVHRS devices and the Operating Manual of the EV1000NI will be updated on its next release. Edwards Lifesciences is currently working on design changes to avoid the potential for damage to the device and to detect whether damage has been sustained during use. This action has been closed-out on 11/08/2016.

Device

Edwards Lifesciences Heart Reference Sensor

Manufacturer

Edwards Lifesciences Pty Ltd