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-01275-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-05
  • 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-01275-1
  • 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
    Issue 1: the mrx can be susceptible to interference from electrical fast transients (efts) when connected to ac or dc power, operating with a lan cable, or operating near a source of eft interference, which could cause therapy to be delayed or delivered inadvertently.Issue 2: if a user undertakes certain atypical clinical workflows (ie, when using external paddles for defibrillation or when using the periodic clinical data transmission (pcdt) option on the mrx), the mrx can exhibit unexpected behaviour. these workflows do not correspond to instructions in the mrx instructions for use (ifu) and are not expected to be performed by trained clinicians. in addition, these device behaviours have only been observed during internal testing, and have not been reported during clinical use. issue 3: the mrx could stop demand mode pacing due to an ecg leads-off condition when electrode-to-skin contact impedance values are outside design ranges for detection.
  • Action
    A software upgrade will be implemented for all units affected by one or more of the above issues. Users are advised that they can continue to use their MRx prior to receiving the software upgrade, provided they follow the temporary workaround instructions provided in the customer letter.

Device

Philips HeartStart MRx Monitor/Defibrillator

Manufacturer

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