Events

Rappel de Philips HeartStart MRx Monitor/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-2014-RN-01288-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-09
  • 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-2014-RN-01288-1
  • 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
    The mrx can be susceptible to one or both of the issues described below:-1.) the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx monitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filterline fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use. a life threatening situation could occur if etco2 is unavailable and the clinician has no other reliable method for determining c02 statusincluding proper intubation without dislodgement.2.) the handle can separate from the mrx housing due to breakage of mounts on the rear case. this is a drop hazard and may potentially cause bodily injury or failure to deliver therapy due to the unit becoming damaged during impact.
  • Action
    Philips is initiating a correction to affected devices. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Philips HeartStart MRx Monitor/DefibrillatorModel Number: M3535ASerial Numbers: US00100100 to US00552845Model Number: M3536ASerial Numbers: US00100902 to US00552848ARTG 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