Events

Retiro De Equipo (Recall) de CONTOURA BARIATRIC BED

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
    76744
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-08
  • 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
    The contoura 1000/1080 range beds are intended to be used as a bariatric medical device which is designed for patients with bmi >40. the devices have been made in accordance to the specification and cannot be descibed as defective. however if the device is used in contradiction to its intended use there is a low but existing entrapment risk for a patient being treated on this bed while being under this bmi level as not all patients are at equal risk for entrapment. in particular small lightweight patients are generally at the greatest risk for entrapment because their small physical dimensions may enhance their ability to fit into a gap in whole or in part. to help the users of these devices to always be aware of the intended use and therefore increase safety we offer additional labeling indicating that the bed is designed for patients with bmi >40. the instruction for use will contain more details on the issue and additional labels will be placed on the bed frame.

Device

CONTOURA BARIATRIC BED
  • Modelo / Serial
    Model Catalog: C1000 (Lot serial: ); Model Catalog: C1080 (Lot serial: )
  • Descripción del producto
    CONTOURA BARIATRIC BED
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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