Events

Retiro De Equipo (Recall) de Device Recall A3/A5 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 Mindray DS USA, Inc. dba Mindray North America.

¿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
    79133
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0846-2018
  • Fecha de inicio del evento
    2017-07-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161422
  • 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 software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
  • Acción
    Mindray sent an Urgent Medical Device Correction letter dated June 9, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Corrective Action: In order to eliminate any potential for the EEPROM issue to manifest, Mindray is offering two options for upgrading affected systems in your facility: Option 1: You may perform the software upgrade if your facility has Biomedical Engineering or other staff that have been trained by Mindray to perform maintenance operations on the ASeries. Please contact Mindray's Technical Support team who will assist with providing the software and instructions for performing the software upgrade. The Technical Support can be reached at (877) 913-9663 (Option 1). Option 2: A Mindray Service Representative will upgrade the affected systems in your facility at no charge. Please contact your Mindray Service Representative to arrange for this upgrade at (877) 913-9663 (Option 8). Both the Technical Support and Service teams may be reached Monday through Friday, 8:30am - 5:30pm, ET.

Device

Device Recall A3/A5 Anesthesia System
  • Modelo / Serial
    Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide
  • Descripción del producto
    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) || Product Usage: || The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America