Events

Retiro De Equipo (Recall) de Philips IntelliVue Patient Monitors

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-2016-RN-01025-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-04
  • 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-2016-RN-01025-1
  • 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
    If an affected patient monitor has been powered on continuously for several months, any displayed waveforms will contain out-dated data and therefore fail to reflect the patient’s current condition. even if out-dated waveforms are displayed as a result of this problem, the monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data. the length of time that a monitor must be powered on before the problem occurs depends on the selected wave speed. it ranges from 102 days (@50 mm/s) to 820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default wave speed of 25 mm/s. the monitor must be powered off in order to avoid this problem. simply placing it in stand-by mode is not sufficient. please note that connected devices, such as central monitors continue to display the correct wave data.
  • Acción
    Philips Healthcare is advising users to cycle the power on the affected devices on a monthly basis. A software upgrade will be implemented as a permanent correction.

Device

Philips IntelliVue Patient Monitors
  • Modelo / Serial
    Philips IntelliVue Patient MonitorsModel Numbers: MX400, MX430, MX450, MX500, MX550Product Codes: 866060, 866061, 866062, 8066064, 866066ARTG Number: 213953
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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