Events

Retiro De Equipo (Recall) de MEDRAD Veris MR Vital Signs Monitor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Imaxeon 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-2013-RN-01312-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-11
  • 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-2013-RN-01312-1
  • 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
    Bayer healthcare has identified that the main board, p/n 301641, installed in some medrad veris mr monitors units may be faulty and could lead to unexpected shutdown of the system while in use. this would result in the loss of vital signs information from the monitor. failure of the monitor may not only result in an inability of the user to view vital signs information but this failure may also go unrecognised. this may present an increased risk to patients who required that their vital signs be monitored while undergoing an mri exam such as those who are sedated, anesthetised or who are on critical medications. thus, it is required to continually monitor the system to ensure proper functioning.
  • Acción
    For those with affected units, Imaxeon Service Representative will be in contact to schedule an appointment to come and replace the main board. Imaxeon have established a prioritisation plan for the corrections which first addresses customers who have reported the problem and those who have the most critical medical diagnostic needs

Device

MEDRAD Veris MR Vital Signs Monitor
  • Modelo / Serial
    MEDRAD Veris MR Vital Signs Monitor Monitor serial numbers : 31710, 31031, 32507, 32551, 32884, 32897, 36417, 38312Monitors containing main board (P/N 3010641) lot numbers 21-39ARTG number: 118213
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DHTGA