Events

Retiro De Equipo (Recall) de Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18

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-01173-1
  • Clase de Riesgo del Evento
    Class I
  • 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-01173-1
  • 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 that involves the v-series drug calculator function specific to weight based calculations. this issue may occur when the patient’s weight is entered using either the v-series patient information dialog or the panorama central station (if it's in use with the central station). if the weight is manually entered, the issue will not occur. depending on the version of software in use, the most recent weight entered into the v-series patient setup dialog or the panorama central station may not be received by the calculator feature; the calculator may retain the original weight entered. additionally, the weight that is displayed in the drug calculator dialog may not reflect what was used for the calculation.If an incorrect dosing calculation results and medication is administered, immediate and/or long term health consequences may result depending on drug, dose, and duration.There are no reports of injuries associated with these issues.
  • Acción
    Mindray is recommending that customers discontinue use of the Drug Calculator function until the software correction is performed. This action has been closed-out on 26/08/2016.

Device

Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18
  • Modelo / Serial
    Mindray's V-Series Patient Monitors, software versions 2.4.0.18, 2.4.0.50, 2.4.0.60 and 2.4.1.18 Model Numbers: 1412 & 1414Serial Numbers: EGL19008969, EGL1B009996, EGL1B010000, EGL1B010014, EGL1B010016, EGL1B010341, EGL1B010352, EGL1C010807ARTG Numbers: 223384
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA