Events

Retiro De Equipo (Recall) de Acuity Central Monitoring Systems

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

¿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-2013-RN-01319-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-13
  • 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-2013-RN-01319-1
  • 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
    There is a potential issue with the acuity central monitoring systems due to the performance of the nvidia nvs300x display cards, which may cause an unexpected cpu reboot to occur. during an acuity reboot, centralised monitoring of some or all patients temporarily ceases, however bedside monitoring and alarming for any change of patient condition continues normally.
  • Acción
    Welch Allyn will be providing replacement CPUs with unaffected NVS450 card installed to customers.

Device

Acuity Central Monitoring Systems

Manufacturer

Welch Allyn Australia Pty Limited