Events

Retiro De Equipo (Recall) de Philips IntelliVue Information Center (PIIC) iX system (A Centralized 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-2015-RN-00077-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-30
  • 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-2015-RN-00077-1
  • 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 is informing that a software defect has been identified that involves the use of the “change bed label” feature at the information center ix. if the configuration for this item is set to “optional” and a user selects the “location” button within the “manage patient” menu and makes a change to the patient location, alarms for sp02 and/or non invasive blood pressure (nbp) will become disabled without visual notification (bell with an “x”) to the user. this problem only happens when the patient is monitored using a networked intellivue trx telemetry m4841/trx4851a patient worn device (pwd).
  • Acción
    Philips is providing instructions to the users to prevent this issue from occurring: Customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from ‘Optional to ‘Hidden’ 2) All patient transfers must be performed using the Transfer key in the Manage Patient application. Philips is providing a software correction to customers with impacted devices at no charge. This action has been closed-out on 08/08/2016.

Device

Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)
  • Modelo / Serial
    Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)Part Numbers: 866023 (IntelliVue Info Center iX), 866024 (PIIC iX Upgrade), 866117 (PIIC Classic Upgrade)Serial Numbers: Release A.00, A.01 and A.02 versions in use with M4841A/TRx4851 telemetry devicesARTG Number: 94237
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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