Events

Retiro De Equipo (Recall) de Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & IntelliSave AX700

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Proact Medical Systems (Australia) 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-00126-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-24
  • 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-00126-1
  • 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
    The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function. it can be brought up to working condition again by simply pulling it out. the control dial is part of the user interface and serves an important role in setting and controlling the anaesthesia machine functions as it is used to adjust and confirm settings made by the user. for siesta i breasy, siesta i whispa and mri 508 freshgas regulation and ventilator mode change (manual or ventilator) can still be done as this is mechanical and/or soft key controlled and doesn’t need confirmation by the control dial.For siesta i ts and intellisave ax700 it is not possible to regulate freshgas delivery or change ventilator mode as this needs confirmation by the control dial.For all machine types ventilation will continue at the previously set parameters.
  • Acción
    Device Technologies is requesting all its customers to check their machines for the faulty control dial and is replacing control dials on devices exhibiting the issue. End users are provided work around instructions to assist in the continued use of affected units. The anesthesia machine can continue to be used as the control dial can be pulled out, making the control dial work. This action has been closed-out on 08/08/2016.

Device

Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & Inte...
  • Modelo / Serial
    Philips Anaesthesia Machines Siesta i Breasy, Siesta i Whispa, Dameca MRI 508, Siesta i TS & IntelliSave AX700Siesta i BreasyProduct Numbers: 866204/10652-00Siesta i WhispaProduct Numbers: 866202/10651-00Dameca MRI 508 Product Numbers: 866203/10651MRI-00Siesta i TS Product Numbers: 866163/10653-00IntelliSave AX700 Product Numbers: 866205/10623-00Multiple Serial Numbers affectedARTG Number: 176848
  • Manufacturer
    Proact Medical Systems (Australia) Pty Ltd

Manufacturer

Proact Medical Systems (Australia) Pty Ltd