Events

Retiro De Equipo (Recall) de IntelliVue MX40 Software Versions: B.00.x and B.01.x

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-2014-RN-00676-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-06-25
  • 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-2014-RN-00676-1
  • 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 alarm pause time is user selectable from 1 to 3 minutes, with a default of 2 minutes, when operating the mx40 with the piic ix.When the following specific conditions are met, the alarm pause time does not automatically restart when it reaches its selected time limit:- the pause alarms configuration is enabled in the non-default setting of both red and yellow level alarms;- the mx40 is selected for the non-default setting of monitor mode;- the pause alarms is initiated to pause an active alarm or to maintain a short ‘non-alarm’ state while in the patient’s vicinity; and- an alarm condition occurs during the pause alarms time.The mx40 will continue to display “alarms paused: 0:00” and the piic ix will display “alarms paused” until the pause alarms feature is disabled manually.
  • Acción
    Philips is advising their customers that the following two items must be configured when using the MX40 with the IntelliVue Information Center iX: 1. Utilise the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms. 2. Utilise the default state of Remote Suspend Alarms as off, which disables the use of the Pause Alarm feature of the MX40 device. Philips will implement a software update to correct the issue. This action has been closed-out on 12/02/2016.

Device

IntelliVue MX40 Software Versions: B.00.x and B.01.x
  • Modelo / Serial
    IntelliVue MX40 Software Versions: B.00.x and B.01.xPart Numbers: 865350 and 865352ARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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