Events

Retiro De Equipo (Recall) de Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 099800302401

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 Mindray DS USA, Inc., dba Datascope Patient Monitoring.

¿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
    54851
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1313-2010
  • Fecha de inicio del evento
    2010-03-05
  • Fecha de publicación del evento
    2010-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89325
  • 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
    An issue affecting the caster mount on the as3000 system have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
  • Acción
    An "URGENT PRODUCT FIELD CORRECTIVE ACTION" letter dated March 5, 2010 was sent certified mail to all facilities/customers that have the AS3000 units. The letter described the product, problem and corrective Action/remediation by the firm. A Mindray Service Representative will contact the customers to arrange for the caster mounts to be replaced on the AS3000 units in their facilities at no cost. If you have any questions, please contact Karen Maine of the Mindray DS USA, Inc. Marketing Department at 201-995-8612 or k.maine@mindray.com.

Device

Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 099800302401
  • Modelo / Serial
    Product numbers 0998-00-3024-01.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA and Mexico, Columbia, Turks & Caicos Islands, BWI; Ecuador, Bolivia, Peru, Dominican Republic, Netherlands Antilles, Chile.SA
  • Descripción del producto
    Datascope AS3000 Anesthesia System; || Mindray, North America. || The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring