Events

Retiro De Equipo (Recall) de HeartStart MRx and FR3

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-2018-RN-00136-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-14
  • 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-2018-RN-00136-1
  • 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
    Philips is sending formal notice of a medical device labeling correction to ensure the following:-heartstart mrx customers have access to the heartstart mrx addendum as a supplement to the mrx instructions for use (ifu)-heartstart fr3 customers whose q-cpr meters are used on an mrx are aware that certain information contained in the fr3 aed instructions for administrators (ifa) and the fr3 q-cpr meter instructions for use (ifu) also applies to use of the q-cp meters with the mrx.
  • Acción
    In August 2015, Philips distributed a Q-CPR Addendum to the MRx Instructions for Use (IFU). This information was already available in the HeartStart FR3 Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) - this was undertaken under RC-2015-RN-00832-1. Philips is requesting MRx users ensure that their copy of the MRx IFU contains the Addendum. For FR3 customers, ensure that the IFU for any MRx with which your Q-CPR Meter may be used contains the Addendum

Device

HeartStart MRx and FR3
  • Modelo / Serial
    HeartStart MRx and FR3 HeartStart FR3Model Number 861388 and 861389 Q-CPR Model Number 989803149941ARTG: 280486HeartStart MRxModel Number M3535A and M3536A Q-CPR Model Numbers: 453564145481, 453564257691, 989803162401 and M4761AARTG: 95661 and 261352 (both restricted to no longer include this product)Q-CPR MeterARTG: 213197
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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