Events

Rappel de IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X

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-2018-RN-00494-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-05-21
  • 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-2018-RN-00494-1
  • 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
    Philips has identified that five warning statements are missing from the instructions for use (ifu) for intellivue mx40 ifu software revisions b.05, b.06 and b.06.5x. if users are unaware of the hazards or limitations described in the missing warning statements, they may not properly assess or provide appropriate treatment to a patient being monitored using an intellivue mx40.These ifus are missing warning statements related to monitoring of patients with pacemakers and the interpretation of qt/qtc measurements that were present in earlier revisions of the ifu. a “warning” alerts users to a potential serious outcome, adverse event or safety hazard. failure to observe a warning may result in death or serious injury to a user or patient.To date, no patient harm has been reported as a result of this issue.
  • Action
    Phillips will contact affected customers to provide a copy of an Instructions For Use (IFU) Errata. Customers are requested to attach the Errata Sheet to the first page of Chapter 6 of the IFU.

Device

IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X

Manufacturer

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