Events

Rappel de Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5 and M3536M6 (manual defibrillator)

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-2012-RN-00736-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-07-19
  • 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-2012-RN-00736-3
  • 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
    When heartstart mrx defibrillator monitors are used in external transport and ems environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads cpr therapy cable and external paddles cable) and the mrx therapy connection port may experience higher than expected levels of stress causing accelerated wear.
  • Action
    Philips is revising the Instructions for Use (IFU) to include additional requirements and instructions for ongoing inspections of these devices, informing users that the lifespan of this device is 3 years and is providing support for users needing to replace cables.

Device

Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M...
  • Modèle / numéro de série
    Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5 and M3536M6 (manual defibrillator)All units manufactured prior to June 2012 (Model / manufacture date is printed on the primary label on the back of battery bay B)ARTG Number: 95661
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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