Events

Retiro De Equipo (Recall) de Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)

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-2012-RN-01207-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-12-07
  • 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-01207-1
  • 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 become aware that specified tcm4 series base units do not comply with the medical safety standard iec 60601-1, 2nd edition, subclause 15(b).The implication is that there is a potential risk of receiving an electric shock under certain conditions as follows:the monitor is connected to the mains outlet and the mains switch is on; the battery is fully charged (or no battery is present); the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor to off; the operator touches the two metal pins on the mains plug or on the monitor's line cord receptacle after disconnecting the line cord.
  • Acción
    Radiometer is informing users of the issue and is providing fluorescent warning stickers to be placed on the device and work around instructions to mitigate the risk if the device must be used. A hardware correction is forthcoming to permanently correct the problem.

Device

Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)
  • Modelo / Serial
    Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)Multiple item numbers and serial numbersARTG Numbers: 119074, 133015 & 133014
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd