Events

Retiro De Equipo (Recall) de 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
    133480
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-02
  • 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
    Invacare has recently identified a supplier quality issue involving the electrical component of invacare spj+ joysticks and invacare mk6i driver controls (excluding all asl sip-n-puff and switch control systems) on some invacare power wheelchair models. the defect may result in the power wheelchair slowing down relative to the commanded speed and then recovering creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects which has led to four confirmed minor injuries which included bruising pinched fingers and pinched hands.

Device

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

Manufacturer

INVACARE CORPORATION