Events

Retiro De Equipo (Recall) de Servoi Ventilator Systems

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 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
    58793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2628-2011
  • Fecha de inicio del evento
    2011-04-20
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100305
  • 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
    Through customer complaints, maquet has been informed that servo-i ventilators have stopped to ventilate and have generated three different technical error codes.
  • Acción
    Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.

Device

Servoi Ventilator Systems
  • Modelo / Serial
    Article number 64 87 800; all units
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    Servo-i Ventilator Systems; Article number 64 87 800 || Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents.
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Dirección del fabricante
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA