Events

Retiro De Equipo (Recall) de CARESTATION 650

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
    66825
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-05-16
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the carestation 620 650 and 650c. an unexpected transition to a system malfunction state can occur on the carestation 600 series systems. when this does occur you will see this message displayed on the screen: "system malfunction internal problem prevents normal operation. use backup ventilation. to restart turn power off and on." if the system malfunction is left unresolved it could result in loss of mechanical patient ventilation which could lead to hypoxia.

Device

CARESTATION 650
  • Modelo / Serial
    Model Catalog: 1012-9650-000 (Lot serial: SM716430070MA); Model Catalog: 1012-9650-000 (Lot serial: SM717020049MA); Model Catalog: 1012-9650-000 (Lot serial: SM716200045MA); Model Catalog: 1012-9650-000 (Lot serial: SM717100033MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080059MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080058MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080057MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080056MA); Model Catalog: 1012-9650-000 (Lot serial: SM717100036MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100027MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430026MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310029MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430025MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100155MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100018MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310012MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100026MA); Model Catalog: 1012-9620-000 (Lot ser
  • Descripción del producto
    CARESTATION 650;CARESTATION 620
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)