Events

Retiro De Equipo (Recall) de Vapotherm

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Vapotherm, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    69116
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2704-2014
  • Fecha de inicio del evento
    2014-08-13
  • Fecha de publicación del evento
    2014-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129676
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Causa
    Disposable patient circuit that allows water to leak into the center gas lumen.
  • Acción
    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
  • Modelo / Serial
    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).
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Vapotherm, Inc., 22 Industrial Dr Ste 1, Exeter NH 03833-4557
  • Empresa matriz del fabricante (2017)
    Vapotherm Inc.
  • Source
    USFDA