Retiro De Equipo (Recall) de GE Carescape Patient 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 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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 manufacturer has determined that selected software versions of b650 and b850 patient monitors have a number of safety related issues including:, 1. non-invasive blood pressure (nibp) auto-cycling will not start, 2. nibp auto-cycling stops when selecting audio & display off, 3. nibp auto-cycling stops when loading data and measuirng nibp at the same time, 4. lost nibp measurements, 5. nibp limit values for infants change when loading a new patient data from a tram module, 6. wrong ecg bandwith in e-psm(p) or e-(p)re(s)tn modules, 7. changing the primary ecg lead selection in the cic pro central station will not change the primary measurement lead in pdm or tram measurement modules, 8. a temp hidden alarm message will not re-activate if a different alarm is acknowledged at icentral, 9. missing audible alarms from remote monitors after broken network connection, 10. missing ecg waveforms on icentral., 11. icentral does not notice a monitor exiting the standby mode, + 14 other issues.
  • Acción
    Software to be upgraded