Events

Rappel de Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.

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-2015-RN-00832-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-08-28
  • 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-2015-RN-00832-1
  • 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
    Adhesive pads:during internal review, philips identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. patient chest injury:instructions did not inform the users that properly performed cpr can result in injuries to the patient.
  • Action
    Philips has updated the HeartStart MRx’s Instructions for Use associated with Q-CPR meter and CPR sensor via an addendum. The addendum has instructions on application of the disposable adhesive pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and orientation of this pad. In addition, the addendum includes general information on the types of injuries, which may occur during CPR. This action has been closed-out on 24/08/2016.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and ...
  • Modèle / numéro de série
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.Units Affected: All Q-CPR meter and CPR sensor, models 453564145481, 453564257691, and M4761A are affected.ARTG: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA