Events

Retiro De Equipo (Recall) de Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Resmed 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-2016-RN-00050-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-18
  • 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-2016-RN-00050-2
  • 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
    Astral devices may experience an issue when powered by an external battery (astral external battery or rps ii). the issue can prevent the user from powering on the device after the auto power off feature powers off the device when there has been no user interaction with the device for 15 minutes and the ventilator is in stand-by.The external battery start up issue only affects astral 100 and astral 150 devices with sr1.1 software (sx544-0301).
  • Acción
    ResMed is advising users to contact ResMed technical support to arrange for the installation of a software upgrade which will address the reported issue. Please note that this software upgrade (SX544-0401) addresses the circuit disconnection alarm issue reported previously (RC-2015-RN-00391-1) as well as the external battery power issue reported in this current recall notification. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)
  • Modelo / Serial
    Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)Product Codes 27081 and 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited