Events

Retiro De Equipo (Recall) de Device Recall Newport e360 Ventilator

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 Newport Medical Instruments 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
    50785
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2029-2009
  • Fecha de inicio del evento
    2008-12-15
  • Fecha de publicación del evento
    2009-09-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77302
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    In december 2008, newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. as a result of this upgrade, some customers experienced unexpected device alert alarms. newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. newport condu.
  • Acción
    Newport Medical initally sent out a Field Correction Notice to a limited number consignees dated December 17, 2008 and then the notice was expanded to include all e360 consignees dated June 15, 2009. The firm notified consignees that they have revised the e360 software to version 3.8. A customer verification form was attached to verify upgrade completion. For further questions, contact Newport Customer Technical Support Department at 1-800-451-3111 or +1-714-427-5811 Extension 500.

Device

Device Recall Newport e360 Ventilator
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US (including AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, ME, MI, NJ, NM, NY, OH, OK, OR, PA, UT and VA), Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, England, Finland, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Japan, Jordan, Kazahkstan, Kenya, Korea, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nambia, Nepal, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, AUE, Ukraine, United Kingdom, Yemen Republic and Zimbabwe.
  • Descripción del producto
    Newport e360 Ventilator, Rx only. || The e360 Ventilator System is intended to provide continuous || (endotracheal or tracheostomy [ET] tube) or non-continuous || (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Dirección del fabricante
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA