Events

Retiro De Equipo (Recall) de Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable 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-2012-RN-01136-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-08
  • 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-2012-RN-01136-1
  • 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 failure of the qube compact monitor where the input power can fail even though the power source at the wall has not been interrupted. the monitor automatically goes into battery mode and functions normally, including the low battery alerts, until the batteries become depleted and the monitor turns off. in addition, there is the potential for the qube compact monitor to fail to turn on.
  • Acción
    As an interim measure, Medtel is providing work around instructions to reduce the probability of occurrence. New hardware will be installed to permanently correct the issue as soon as possible.

Device

Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)
  • Modelo / Serial
    Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)Serial Numbers:1390 - 000340, 1390 - 000339, 1390 - 000338 & 1390 - 000337ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA