Events

Rappel de HeartStart MRx and FR3

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00136-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00136-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA