Events

Retiro De Equipo (Recall) de GE CARESCAPE Monitor B850

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Healthcare Finland Oy.

¿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
    15630
  • Fecha de inicio del evento
    2013-11-07
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    The patient data module (pdm) can sometimes spontaneosuly lose the communication withthe host patient monitor when atached to the f5-01 frame due to an issue with the pdm ethernet communication hardware.Communication is not automatically re-established. loss of communication with the host monitor results in a loss of monitoring for the parameters provided by the pdm module.. the parameters may include ecg, spo2, nibp, co, temperature and respiration.
  • Acción
    Product to be modified

Device

GE CARESCAPE Monitor B850

Manufacturer

GE Healthcare Finland Oy