Events

Retiro De Equipo (Recall) de Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015

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-2017-RN-00732-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-06
  • 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-2017-RN-00732-1
  • 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 has identified a higher than expected incidence of speaker failures, which results in the loss of audible alarms when the device is in monitor mode. the failure of the speaker results in the audio capabilities of the speaker being degraded and/or no sound at all. operation in telemetry mode is unaffected by speaker failure until disconnected from the information center, either intentionally or unexpectedly.Monitor mode: the mx40 provides local patient monitoring for a period limited by its battery life. the device will annunciate audible & visual alarms using the speaker & display on the mx40 when the alarm conditions are triggered. extended use in this mode raises the risk of the speaker failing.Telemetry mode: all alarming is automatically managed at the information center. mx40 speaker volume is set to zero & the display is off unless the user enables monitor mode. the device will automatically switch to monitor mode if it loses connection to the telemetry network.
  • Acción
    A Philips Healthcare representative will contact customers with affected devices to arrange for shipment of a replacement unit. The replacement device is currently manufactured with the improved hardware speaker design and latest software (includes speaker detection capability and INOP messaging) release. An interim workaround is also given in the Customer Letter until such time as the replacement can be made.

Device

Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015
  • Modelo / Serial
    Philips IntelliVue MX40 Wearable Patient Monitors manufactured prior to the 6th of July 2015Product Number: 865351 Service Number: 453564262531 and 453564262551Product Number: 865352Service Number: 453564262571 and 453564262591Serial Numbers: lower than US03556362ARTG Number: 99204
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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