Events

Retiro De Equipo (Recall) de Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)

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-00829-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-25
  • 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-00829-1
  • 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 contact electrostatic discharge (esd) is applied to one of the four screws on the rear enclosure panel of the ip5, the wireless function of the ip5 radio could be interrupted. if this were to occur, there could be a loss of wireless communication between the ip5 and host monitoring system, the expression mri patient monitoring system or the expression mr200 mri patient monitoring system. this could potentially lead to a delay in treatment or diagnosis of the patient.
  • Acción
    A Philips representative will contact affected customers to arrange for the addition of two ferrite clamps to a cable located inside the device to protect against an electrical pulse from ESD. Philips has advised that the IP5 can continue to be used and have provided work around instructions to reduce the risk of electrical pulse from ESD. This action has been closed-out on 1/06/2016.

Device

Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)
  • Modelo / Serial
    Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)Product Code: 865471 Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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