Events

Rappel de SoKINOX NO (Nitric Oxide) Delivery and Monitoring System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet 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-2017-RN-00851-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-12
  • 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-2017-RN-00851-1
  • 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
    Getinge has identified an issue where during no (nitric oxide) therapy, when a no cylinder runs nearly empty the system will indicate this by the "almost empty cylinder" icon. when the cylinder runs empty it will then trigger the alarm no cylinder 1 missing (or empty) or no cylinder 2 missing (or empty). this is indicated on the user interface by a crossed out cylinder icon. the system automatically shifts over to the other cylinder.Due to a pressure increase after the cylinder switch-over there are two possible issues identified:1. the cylinder status icon can change and erroneously indicate remaining gas in an empty no gas cylinder.2. the alarm “no cylinder 1 missing (or empty)” or “no cylinder 2 missing (or empty)” can be deactivatedif the empty no cylinder is not replaced, both no cylinders can run empty and cause a stop in no delivery. to date, there have been no reports of patient injury as a result of this issue.
  • Action
    Getinge/Maquet will initiate an immediate update of all affected SoKINOX systems as soon as the system version 1.3 is released in Australia. Once version 1.3 available, customers will be contacted by a Getinge/Maquet sales or service representative to plan for the update of the device.

Device

SoKINOX NO (Nitric Oxide) Delivery and Monitoring System
  • Modèle / numéro de série
    SoKINOX NO (Nitric Oxide) Delivery and Monitoring SystemDevice Number: 66 94 550ARTG Number: 273803
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA