Events

Retiro De Equipo (Recall) de Lithium Ion Batteries, M4605A and M4607A for use with 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-2014-RN-00514-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-06
  • 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-00514-1
  • 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
    On-going monitoring of quality data by the manufacturer has determined that the risk of battery failure increases with age, when a battery remains in use longer than 3 years after the date of manufacture or 500 charge-discharge cycles. such failure may result in overheating. battery management and safety practices information for the batteries m4605a / m4607a are not clearly documented in the instructions for use for intellivue patient monitors with software releases up to and including g.0. overheating of the battery may cause the battery to ignite or explode, which may result in injury to a patient or user.
  • Acción
    Philips is initiating this correction to provide an Addendum to the Instructions for Use for IntelliVue Patient Monitors with software releases up to and including G.0. The addendum describes that batteries M4605A / M4607A should be replaced after 3 years of continuous use after date of manufacture or 500 battery charge-discharge cycles. The addendum to the IntelliVue Patient Monitor IFU is included with the customer letter. This action has been closed-out on 10/02/2016.

Device

Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient Monitors
  • Modelo / Serial
    Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient MonitorsModel numbers of the affected patient monitors :MP2, X2, MP5, MP20, MP30, MP40, MP50Product numbers: M3002A, M8102A, M8105A, M8105AT, M8001A, M8002A, M8003A, M8004AARTG Number: 94238
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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