Events

Rappel de IntelliSpace Critical Care & Anaesthesia Information Systems

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-00097-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-03
  • 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-00097-1
  • 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
    A software configuration defect has been identified that impacts one standard content (configuration that is shipped with the product) unit of measure (gm/m2) for the body surface area (bsa). the defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. if the user does not identify that an incorrect multiplier exists in the standard content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage).
  • Action
    Users are advised to implement the instructions in the customer letter if the BSA (gm/m2) Standard Content is used in their systems configuration. Philips has initiated a software correction to address this issue. A Philips representative will contact customers to schedule the implementation of this correction. This action has been closed-out on 20/07/2016.

Device

IntelliSpace Critical Care & Anaesthesia Information Systems
  • Modèle / numéro de série
    IntelliSpace Critical Care & Anaesthesia Information SystemsAffected Models:865047 IntelliVue Clinical Information Portfolio (ICIP), Rev D865209 IntelliVue Clinical Information Portfolio (ICIP), Rev E866072 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. F866148 IntelliSpace Critical Care & Anaesthesia (ICCA), Rev. GARTG Number: 98511
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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