Events

Retiro De Equipo (Recall) de Device Recall FLOWI Anesthesia System

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 Maquet Cardiovascular Us Sales, Llc.

¿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
    62118
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1925-2012
  • Fecha de inicio del evento
    2012-02-20
  • Fecha de publicación del evento
    2012-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109875
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    A technical alarm may be generated on the flow-i system when using the man/auto switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.
  • Acción
    The firm, Maquet Getinge Group, sent an "URGENT DEVICE FIELD CORRECTION" letter dated February 20, 2012 to its customers. The letter describes the product, problem and action to be taken. The letter state that a Maquet Service Representative will upgrade the customers software in the FLOW-i Anesthesia System to the current revision and also provide the customers with the corresponding user's manual. Note: This upgrade includes other minor improvements. The customers were instructed to sign a document to verify satisfactory completion of the work once the software upgrade was completed. If you have questions or require additional information, please contact your local MAQUET representative or Technical Support at 888-627-8383. A press release was issued on 7/6/2012.

Device

Device Recall FLOWI Anesthesia System
  • Modelo / Serial
    Model Number :6677300 Serial Number : 1170
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    FLOW-I Anesthesia System || The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Dirección del fabricante
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA