Events

Retiro De Equipo (Recall) de Astral Ventilators

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-2015-RN-00391-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-12
  • 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-00391-1
  • 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
    Resmed received an incident report involving circuit disconnection of a patient in a hospital where the device alarms did not operate because all alarms had been disengaged by the physician and the patient required medical intervention.
  • Acción
    ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur. Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. ResMed intends to release and install an updated version of Astral software, in three months’ time, in which the circuit disconnection alarm for all ventilation modes for dependent patients cannot be deactivated. For more details, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators
  • Modelo / Serial
    Astral VentilatorsAstral 100Model No: 27081Astral 150Model No: 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited