Events

Retiro De Equipo (Recall) de Radiometer TCM5 Flex Monitor (non-invasive blood gas 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 Radiometer Pacific 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-2016-RN-01264-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-23
  • 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-2016-RN-01264-1
  • 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
    Radiometer has recently become aware of a potential risk that the tcm5 monitor may not be compliant with the waterproof specification, ipx2, which is required for a homecare environment. the problem is caused by incorrect assembly and may allow water to enter into the monitor, which may pose a risk of electrical shock for the user. there have been no reports of injuries as a result of this issue.
  • Acción
    Radiometer is advising users to stop use of the affected devices until they have been inspected and repaired where required by a Radiometer representative. A loan unit will be provided while the device is being repaired. This action has been closed-out on 17/05/2017.

Device

Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)
  • Modelo / Serial
    Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)Serial Numbers: below 393-500R0030N009ARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd