Events

Retiro De Equipo (Recall) de qube Compact Monitor (Transportable mutiparameter patient monitor)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtel 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-00712-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-04
  • 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-00712-1
  • 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
    There is a potential issue with the qube compact monitors that are “docking station ready” that have had a port cover plate removed allowing the monitor to be used with the optional qube docking station. if a docking station ready qube monitor is powered up undocked, connected to the network via an ethernet hardwire connection, and then disconnected from the ethernet hardwire connection and inserted into a qube docking station, a switch condition will cause the monitor to lose the network connection. all bedside alarms will continue to function normally.
  • Acción
    If the users dock the monitor and lose network connection, power down the monitor and turn it back on to restore normal function. To prevent this error from happening, users are advised to avoid transitioning from hardwire ethernet connection to a docking station without powering down the device. Medtel Pty Ltd will contact affected sites to schedule a convenient time to correct the sites affected qube monitors.

Device

qube Compact Monitor (Transportable mutiparameter patient monitor)
  • Modelo / Serial
    qube Compact Monitor (Transportable mutiparameter patient monitor)Catalogue Number: 91390Serial Numbers: 1390-000290, 1390-000291, 1390-000337, 1390-000338, 1390-000339, 1390-000340, 1390-000607, 1390-000608, 1390-000609, 1390-000610, 1390-000689, 1390-000690, 1390-000691,1390-000692, 1390-000693, 1390-000695, 1390-100047, 1390-100048, 1390-101245, 1390-102559, 1390-102560, 1390-102561, 1390-102562, 1390-102563ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA