Events

Retiro De Equipo (Recall) de Xper Flex Cardio 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-01105-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-20
  • 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-01105-1
  • 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 spo2 and non-invasive blood pressure (nibp) waveform and numeric values displayed on the device may freeze, resulting in the display of measurements that are not current. should this problem occur, spo2 and nibp will no longer function, including alarms. this may result in a delay in detecting important changes in a patient’s cardiovascular and respiratory condition.
  • Acción
    Philips is advising users that the devices can continue to be used provided that each monitored patient is closely observed by a qualified healthcare professional. A software upgrade will be installed on all affected devices as a permanent correction.

Device

Xper Flex Cardio Patient Monitoring System
  • Modelo / Serial
    Xper Flex Cardio Patient Monitoring SystemModel Numbers: FC2010 and FC2020All systems distributed prior to September 2015ARTG Number: 229631
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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