Retiro De Equipo (Recall) de JOERNS HEALTHCARE EASYCARE BED

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOERNS HEALTHCARE CANADA 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
    72142
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-10-07
  • País del evento
  • 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
    Joerns healthcare has identified an issue with easycare beds configured w/the care-lock system where in some instances the care-lock system after being engaged by stepping on the red or right side pedal through normal daily use and patient/care-giver interaction with the bed can disengage i.E. revert to a non-locked state. the care-lock system is located at the foot end of the bed there are also steering locks located on the dual wheel casters at the head of the bed. this does not affect the steering locks located on the dual wheel casters at the head of the bed.

Device

  • Modelo / Serial
    Model Catalog: EASYCARE (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    JOERNS HEALTHCARE EASYCARE BED
  • Manufacturer

Manufacturer