Events

Retiro De Equipo (Recall) de ARJO TENOR MOBILE LIFT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ARJO 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
    74502
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-15
  • 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
    During use with the tenor without scale unit the part# ten.018 bolt is subjected to mechanical forces which may lead to breakage due to the design of the connection between spreader bar and lifting arm jig. the current design of suspension of the tenor spreader bar is causing adverse bending tension on suspension bolt ten.018 during specific use situations such as the load mass of the patient is unevenly placed in the sling the caregiver attempts to move the lift by pushing or pulling the suspended patient body sling or spreader bar. this is revealed in long term use as metal fatigue and the formation of micro-cracks in the thread.

Device

ARJO TENOR MOBILE LIFT
  • Modelo / Serial
    Model Catalog: KHA1000-US (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    Tenor Mobile Patient Lifter (non-scale version)
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

ARJO CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC