Events

Retiro De Equipo (Recall) de Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2016-RN-00107-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-28
  • 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-00107-1
  • 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
    Philips respironics has become aware that trilogy ventilators with the affected software versions and dual therapy prescriptions are susceptible to an inadvertent change between prescriptions. this may occur under a particular set of operating conditions without requiring confirmation of the change by the user.- device connected to the ac power source- device software versions 13.2.04, 13.2.05, 14.0.0 or 14.1.01- dual prescription is on- menu access is limited- device powered on- the device is allowed to operate for 5 or more minutes without pressing the up arrow keypressing the right key selects the “switch to secondary settings” menu. pressing the right key again within the next 30 seconds, confirms the “switch to secondary settings” and the device will switch from the primary to the secondary settings. the devices continue to display the active prescription in the upper left hand corner of the display, however, the user may be unaware of this change.
  • Acción
    Philips is advising users that there is a software update available (my.respironics.com) for users to upgrade the device software to version 14.1.02. This action has been closed out 01 Feb 2017.

Device

Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01
  • Modelo / Serial
    Trilogy dual prescription ventilators with software versions 13.2.04, 13.2.05, 14.0.00, and 14.1.01Model Numbers: 100 and 202ARTG Numbers: 159490 and 174169
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA