Events

Retiro De Equipo (Recall) de CARESCAPE R860

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    78518
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-28
  • 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 following issue is being addressed by ge healthcare file no. fmi 34066: the evair component manufacturer imtmedical ag is conducting a field corrective action. imtmedical has identified that potential friction of cables and tubing internal to the evair compressor may result in an inability for the compressor to output compressed air. there is a potential for temporary oversupply of oxygen to the patient as a result of this failure because the ge healthcare ventilators are designed to ventilate with 100% oxygen in the case of loss of input air supply pressure.

Device

CARESCAPE R860

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)