Events

Retiro De Equipo (Recall) de PATIENT DATA MODULE

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
    58986
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-08-27
  • 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 36107: if the pdm is quickly disconnected and reconnected (a less than 10 second cycle) from a carescape bx50 monitor following a "patient discharge" or during active monitoring the ecg waveform and its associated waveform parameters could be analyzed incorrectly. the ecg heart rate (hr) parameter data the ecg waveform analysis and other ecg parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. as a result of the abnormal analysis of data the alarms for serious conditions may not be triggered appropriately. the issue potentially affects heart rate ecg st segment analysis 12 lead ecg analysis ecg spo2 respiration and invasive blood pressure waveforms both locally and at cic and data displayed at cic may show data drop out. neither bedside nor cic data can reliably represent the parameters being measured. if your facility uses the pdm only with transport pro or solar monitors the issue does not exist.

Device

PATIENT DATA MODULE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)