Events

Retiro De Equipo (Recall) de IntelliSpace Critical Care & Anaesthesia Information Systems

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-00097-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-03
  • 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-00097-1
  • 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
    A software configuration defect has been identified that impacts one standard content (configuration that is shipped with the product) unit of measure (gm/m2) for the body surface area (bsa). the defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. if the user does not identify that an incorrect multiplier exists in the standard content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage).
  • Acción
    Users are advised to implement the instructions in the customer letter if the BSA (gm/m2) Standard Content is used in their systems configuration. Philips has initiated a software correction to address this issue. A Philips representative will contact customers to schedule the implementation of this correction. This action has been closed-out on 20/07/2016.

Device

IntelliSpace Critical Care & Anaesthesia Information Systems
  • Modelo / Serial
    IntelliSpace Critical Care & Anaesthesia Information SystemsAffected Models:865047 IntelliVue Clinical Information Portfolio (ICIP), Rev D865209 IntelliVue Clinical Information Portfolio (ICIP), Rev E866072 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. F866148 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. GARTG Number: 98511
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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