Events

Retiro De Equipo (Recall) de M41 POWER WHEELCHAIR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INVACARE CORPORATION.

¿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
    129378
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-09
  • 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
    M41 power wheelchairs received through invacare service parts (isp) have controllers that were programmed in a way that is not aligned to standard factory settings. while highly dependent on external circumstances different settings including max forward speed max forward acceleration max reverse speed and max turning speed can result in momentary loss of control. at no time however will the chair move without user activation of the joystick or fail to come to a stop when the user releases the joystick or shuts off the device.

Device

M41 POWER WHEELCHAIR
  • Modelo / Serial
    Model Catalog: 1143839 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    INVACARE PRONTO M41 POWER WHEELCHAIR CONTROLLERS
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION