Events

Retiro De Equipo (Recall) de Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring system)

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-01029-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-24
  • 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-2014-RN-01029-1
  • 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
    Continuous use of the ip5 for more than 24 days, without power cycling, results in a graphical user interface (display screen) error, which causes the numeric data on the display to freeze and disables some menu keys. waveform data displayed and audible alarms are not impacted by this problem and continue to function properly. this could result in delay in treatment of the patient caused by the displayed numeric value not correlating with the patient's status.This is an update to the previous recall for product correction (tga ref.: rc-2014-rn-00349-1) which informed end users to ensure that the ip5 should be power cycled every 24 hours to prevent the above issue from occurring. now a permanent software solution is available.
  • Acción
    A Philips representative will contact the customers and all affected devices will have a software update installed in order to address the problem. After the software update is installed, if the device is allowed to run for an extended period of time, the device will begin to notify users of the need to power cycle the device using various degrees of warning “restart required” prompts (dialog boxes). If the device is not power cycled when this time expires, the device will power down and sound a tone to inform users of the action. Until the software solution is implemented, users should ensure that the IP5 is power cycled once every day. This action has been closed-out on 5/08/2016.

Device

Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient mo...
  • Modelo / Serial
    Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring system)Product Code: 865471 Service Number 453564251511Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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