Events

Retiro De Equipo (Recall) de Rechargable Lithium Ion Battery used in Beneview T1 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 Mindray Medical Australia Pty 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-2017-RN-01065-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-16
  • 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-2017-RN-01065-1
  • 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
    Mindray has identified the potential for overheating of the rechargeable lithium ion battery used in beneview t1 patient monitors. the initial failure mode and clinical assessment indicated that the problem may result in the battery overheating, smoke, and the possible melting of the monitor shell under extreme circumstances. to date, there are no reports of patient injuries associated with this potential issue.
  • Acción
    1. Pass this Notice to all within your organisation or to any organisation where the potentially affected device(s) have been transferred. 2. Stop using the Rechargeable Lithium Ion battery of Beneview T1 Patient Monitor. Mindray service representatives will contact users to replace the affected batteries. 3. Store the affected batteries properly as follows; · Do not charge batteries. · Prevent short circuiting of the batteries. For example, covering the two ends of the connector with insulating tape. · Store the batteries at cool places(=21°C) away from combustibles. · Store the batteries separately, do not mix, overlay or pile up them with other batteries. 4. Mindray Service Representatives will visit to collect and dispose of the batteries.

Device

Rechargable Lithium Ion Battery used in Beneview T1 Patient Monitors
  • Modelo / Serial
    Rechargable Lithium Ion Battery used in Beneview T1 Patient MonitorsMultiple Battery Serial NumbersARTG Number:223384
  • Manufacturer
    Mindray Medical Australia Pty Ltd

Manufacturer

Mindray Medical Australia Pty Ltd