Events

Rappel de Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, 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-00738-3
  • 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-00738-3
  • 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
    Some heartstart mrx monitor/defibrillators may contain compromised electronic components and present the following behaviours:·in automatic external defibrillator (aed) mode, the mrx may have difficulty interpreting the pads ecg waveform. the mrx may incorrectly analyse the rhythm or may fail to analyse the rhythm.· in manual defibrillation mode, if the pads/paddles ecg signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.· when using q-cpr measurement and feedback, the feedback on ventilation rate may be inaccurate.
  • Action
    Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions.

Device

Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M...
  • Modèle / numéro de série
    Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual defibrillator)Multiple affected units 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