Events

Rappel de Cook Aspiration Unit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook 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-2018-RN-00174-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-26
  • 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-2018-RN-00174-1
  • 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 recent design review of the k-mar-5200 aspiration unit, identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0. iec60601-1. this standard states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. the k-mar-5200 mains wiring is secured, but the mechanism is not considered suitable under iec60601-1.To date, no harm has been reported as a result of this issue.
  • Action
    Cook Medical is advising that they will be replacing the mains wiring for affected each unit. An authorised service agent will contact users to arrange for impacted devices to be corrected. In the interim, Cook Medical recommends that a residual current device (RCD), also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI) is fitted to the mains electricity supply to mitigate the risk of a hazardous situation.

Device

Cook Aspiration Unit
  • Modèle / numéro de série
    Cook Aspiration Unit Part Numbers: K-MAR-5200, K-MAR-5200-USGlobal Product Numbers: G49275, G51067ARTG Number:156032(William A Cook Australia - Suction unit, electric powered)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd