Events

Retiro De Equipo (Recall) de Patient monitor, central unit

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 Medical Systems Information Technologies.

¿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
    22431
  • Fecha de inicio del evento
    2018-01-12
  • 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
    After boot-up or system start up, cscs v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the cscs is connected to both the mission critical (mc) and the information exchange (ix) networks. if a no comm notification is displayed, all patient waveforms, parameter data and alarms are lost at the cscs and patients admitted to telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation.
  • Acción
    Software to be upgraded

Device

Patient monitor, central unit

Manufacturer

GE Medical Systems Information Technologies