Events

Retiro De Equipo (Recall) de Device Recall Maquet Flowi

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
    73137
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0804-2016
  • Fecha de inicio del evento
    2015-12-10
  • Fecha de publicación del evento
    2016-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143153
  • 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
    Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (pcbs) that control the sub-systems. the problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. replacement pcbs are now available to correct the issues. only the model c20 is affected in the us.
  • Acción
    Maquet sent "Urgent Medical Device Field Action Field Correction For Flow-i Anesthesia Systems" letters/Field Correction Response forms dated 12/10/2015 via UPS to affected customers. The notification informed customers of the issue, asked them to distribute the notification to appropriate staff; verify the serial number(s) and informed them they could continue to use the system if they were not experiencing electrical issues. Customers were informed that a Maquet service representative would be contacting them to arrange a time to replace their affected units. Customers were asked to complete and return the enclosed Field Correction Response Form to Maquet at FieldActions@maquet.com or by fax to 973.860.1675. If the customer had any related questions they were instructed to contact Maquet Technical Support at 1.888.627.8383 (option 3; option 1; option 1) Monday through Friday between 8:00 am and 5:00 pm EST.

Device

Device Recall Maquet Flowi
  • Modelo / Serial
    Model numbers: C20, C30 and C40 (Only Model # C20 for US)  Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400  Serial numbers (2743, 2852, 2854, 2855, 2856, 2858
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of CA, NY, and OR
  • Descripción del producto
    Flow-i Anesthesia System || Product Usage: || The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
  • 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