Events

Retiro De Equipo (Recall) de Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32

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-01297-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-07
  • 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-01297-1
  • 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
    When the local "alarms on" configuration setting on the phillips intellivue mx40 patient wearable monitor is modified from its factory default, in certain software revisions, it will disable generation and delivery of ecg alarms to the philips intellivue information center ix (piic ix) without a visual indication on the piic ix that the ecg alarms have been disabled. if the generation and delivery of ecg alarms to the information center is disabled without a corresponding visual indication at the information center, a delay in treatment could occur.
  • Acción
    Phillips is implementing software upgrade for affected Phillips IntelliVue MX40 Patient Wearable Monitors. Users with affected devices will be contacted by a Phillips Healthcare representative for the installation of the software upgrade. In the interim, users are advised to make sure that the MX40 Patient Wearable Monitor local configuration setting ‘Alarms On’ is configured to its factory default. Philips is providing instructions to change the local configuration settings in the customer letter.

Device

Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32
  • Modelo / Serial
    Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32Product Numbers: 865351, 865352 Exchange Part Numbers: 453564262531, 453564262551, 453564262571, 453564262591, 453564615351, 453564615371Product number and Exchange part number (identified as Service #) are displayed on the devices product label located on the back of the deviceARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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