Events

Retiro De Equipo (Recall) de Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ulco Engineering Pty Ltd.

¿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
    RC-2014-RN-01158-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01158-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Mindray has identified an issue related to the panorama central station where full disclosure data (includes patient data, waveforms, and events) may lag behind the panorama system time clock when the panorama central station is in use with mindray’s v-series monitor. the full disclosure data may be a minimum of 6 seconds behind the panorama system time clock and may grow at a rate of 5 to 7 seconds per day if the v-series monitor remains connected to the panorama central station without interruption. this issue may also lead to the inability to print the most recent “full disclosure” data if the lag time exceeds 21 seconds. if the lag time exceeds 30 seconds, non-invasive blood pressure measurement contained in the “list trends” may appear out of time order. there are no reports of injuries associated with these issues.
  • Acción
    Mindray is arranging software upgrade to eliminate this issue. Customers are advised that a break in communications, admitting or discharging a patient or putting the V-Series in standby will, temporarily, eliminate the issue. This action has been closed-out on 26/08/2016.

Device

Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring Network
  • Modelo / Serial
    Panorama Central Station, software versions 10.0 to 11.3 and patient Monitoring NetworkSerial Number: RM01940-F2ARTG Numbers: 223386
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA