Events

Retiro De Equipo (Recall) de MYNDMOVE FUNCTIONAL ELECTRICAL STIMULATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MYNDTEC 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
    49701
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-05-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    This notice is being circulated to all users with myndmove stimulators with serial numbers 1652014c00xx (serial number shown on label on the bottom of the stimulator) and is intended to address customer complaints related to the high frequency of falsely detected open circuit errors. when encountered the therapy cannot be continued until the error is cleared. this may affect one or more channels. the investigation at myndtec inc. has determined that the root cause of this event is due to a firmware bug affecting the open circuit detection during the calibration pulses before channel set up and before starting treatment. myndtec inc. has corrected this problem in a new version of firmware for myndmove stimulators with serial numbers 1652014c00xx.

Device

MYNDMOVE FUNCTIONAL ELECTRICAL STIMULATOR
  • Modelo / Serial
    Model Catalog: 900165 (Lot serial: s/n: 1652014C0001 to C0022)
  • Descripción del producto
    MYNDMOVE FUNCTIONAL ELECTRICAL STIMULATOR
  • Manufacturer
    MYNDTEC INC.

Manufacturer

MYNDTEC INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Myndtec Inc
  • Source
    HC