Events

Rappel de Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Surgical Specialties 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-2014-RN-00916-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-22
  • 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-2014-RN-00916-1
  • 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
    Vapotherm inc. has received a small number of complaints involving a defect in the disposable patient circuit delivery tube. the defect allows water to leak into the centre lumen of the delivery tube, the gas line to the patient. the fault condition is easily detectable and typically occurs while the device is coming up to the set temperature and is easily visible when following the precision flow instructions for use, which requires that the cannula be connected to the patient only after the set temperature is reached.
  • Action
    Customers are asked to check their stock immediately to determine if they have any affected product. Customers are advised to return the affected stock to Surgical Specialties Pty Ltd. This action has been closed-out on 10/05/2017.

Device

Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cann...
  • Modèle / numéro de série
    Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)Part Numbers: PF-DPC-High, PF-DPC-Low Lot Numbers: HF1402035, HF1404043, LF1402030, LF1405023ARTG Number: 147794
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd