Events

Rappel de Vapotherm

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Vapotherm, Inc..

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
    69116
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2702-2014
  • Date de mise en oeuvre de l'événement
    2014-08-13
  • Date de publication de l'événement
    2014-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129673
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Cause
    Disposable patient circuit that allows water to leak into the center gas lumen.
  • Action
    Vapotherm issued an Initial Notification on August 13, 2014. The letter was updated on August 20, 2014 to include two additional lots. The recall letter notified users that this defect is easily detectable during normal use and the probability of serious injury or death is remote. The letter was sent to raise awareness of the recent increase in incidence rate of this issue and reminded users of the requirement in the operating manual that requires that the cannula be connected to the patient only after the set temperature is reached. The letter also advised patient care personnel not to use, or to discontinue use of any Disposable Patient Circuit if water is observed leaking into the center lumen or from the cannula. They were instructed to replace the device and report the defect to Vapotherm immediately for further investigation. Should you have any questions please contact our technical support team at Email: ts@vtherm.com (US) 855.557.8276 (INTL) 1-603.658.5121

Device

Vapotherm
  • Modèle / numéro de série
    Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.
  • Description du dispositif
    Vapotherm Precision Flow,Disposable Patient Circuit || PF-NODPC-Low. || For use with the Precision Flow system and Ikaria INOmax DSIR || ¿ System. || This DPC allows clinicians to administer nitric oxide non-invasively via high || flow nasal cannula. In the Precision Flow High Flow Therapy application, a || special disposable patient circuit re-routes the gas to the INOmax injector || module then back into the Precision Flow system
  • Manufacturer
    Vapotherm, Inc.

Manufacturer

Vapotherm, Inc.
  • Adresse du fabricant
    Vapotherm, Inc., 22 Industrial Dr Ste 1, Exeter NH 03833-4557
  • Société-mère du fabricant (2017)
    Vapotherm Inc.
  • Source
    USFDA