Retiro De Equipo (Recall) de WATO EX-65 and A-Series (A5/A7) anaesthesia machines

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mindray Medical Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Mindray has identified a potential issue related to electrically erasable programmable read-only memory (eeprom) which will only occur if the system’s total number of write cycles to a particular range of memory locations has exceeded the life specification of the eeprom. the issue will only manifest at start up or at the end of a case; it will not occur during a case. there are no adverse effects on the patient.To date, there have been no reports of injuries associated with this issue.
  • Acción
    The manufacturer recommeds cessation of the use of machines which have experienced this fault. Units which have not experienced the fault may be used as normal. A software upgrade is planned.