Events

Rappel de Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)

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-00829-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-25
  • 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-00829-1
  • 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
    When contact electrostatic discharge (esd) is applied to one of the four screws on the rear enclosure panel of the ip5, the wireless function of the ip5 radio could be interrupted. if this were to occur, there could be a loss of wireless communication between the ip5 and host monitoring system, the expression mri patient monitoring system or the expression mr200 mri patient monitoring system. this could potentially lead to a delay in treatment or diagnosis of the patient.
  • Action
    A Philips representative will contact affected customers to arrange for the addition of two ferrite clamps to a cable located inside the device to protect against an electrical pulse from ESD. Philips has advised that the IP5 can continue to be used and have provided work around instructions to reduce the risk of electrical pulse from ESD. This action has been closed-out on 1/06/2016.

Device

Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)
  • Modèle / numéro de série
    Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)Product Code: 865471 Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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