Events

Rappel de Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Proact Medical Systems (Australia) Pty 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-00707-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-06
  • 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-00707-1
  • 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
    During internal review, philips identified that it was not explicitly described in the instructions for use that the o2 test must be done as part of the daily check to ensure that the machine measures the o2 concentration in the fresh gas correctly, and can deliver the desired o2 concentration in the fresh gas to the patient.Incorrect measurement of o2 concentration in the fresh gas or o2 concentration in the fresh gas not at desired level, can potentially cause hypoxia to the patient.
  • Action
    Review the Recall for Product Correction and the update to the IFU and ensure that the changes are understood and that all personnel using the device are informed about the content in this Recall for Product Correction. This action has been closed-out on 17/08/2016.

Device

Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550...
  • Modèle / numéro de série
    Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256ARTG Number: 176848
  • Manufacturer
    Proact Medical Systems (Australia) Pty Ltd

Manufacturer

Proact Medical Systems (Australia) Pty Ltd