Events

Rappel de Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI procedures)

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-2015-RN-00425-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-18
  • 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-2015-RN-00425-1
  • 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
    Recent revisions of the device’s instructions for use (ifu) (part number 989803162691, rev. f- rev. h) inaccurately indicates that one of the temperature probe’s application sites is “endotracheal”. the application site should be listed as“esophageal”. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.. should the flextemp reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the flextemp temperature sensor or flextemp system jacket is left in the patient upon removal, or if the flextemp system jacket is damaged and sterilization compromised.
  • Action
    Philips is providing the customers with an errata sheet to the Expression IFU, which removes endotracheal as an application site. Philips is working on a solution to this issue and once a solution is available, Philips will provide the customers with another communication outlining the plans for implementing the solution. This action has been closed-out on 24/08/2016.

Device

Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI ...
  • Modèle / numéro de série
    Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI procedures)Product Code: 865214 (In vivo Expression MRI Patient Monitoring System)Serial Numbers: US31204924, US31205148, US31205180, US42707074, US42707166, US42707375, US42707396ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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