Events

Retiro De Equipo (Recall) de 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
    58620
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2468-2011
  • Fecha de inicio del evento
    2009-10-27
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99720
  • 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
    Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
  • Acción
    Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require additional information, please call (714) 427-5811 extension 344.

Device

Newport e360 Ventilator
  • Modelo / Serial
    Serial Numbers: N09360914600, N09360914601, N09361014775 - N09361014786, N09361014874 - N09361014877
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.
  • Descripción del producto
    Newport e360 Ventilator, Model Number: e360 || 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). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Dirección del fabricante
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • 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