Events

Retiro De Equipo (Recall) de Cook Aspiration Unit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia 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-2018-RN-00174-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-26
  • 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-2018-RN-00174-1
  • 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
    A recent design review of the k-mar-5200 aspiration unit, identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0. iec60601-1. this standard states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. the k-mar-5200 mains wiring is secured, but the mechanism is not considered suitable under iec60601-1.To date, no harm has been reported as a result of this issue.
  • Acción
    Cook Medical is advising that they will be replacing the mains wiring for affected each unit. An authorised service agent will contact users to arrange for impacted devices to be corrected. In the interim, Cook Medical recommends that a residual current device (RCD), also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI) is fitted to the mains electricity supply to mitigate the risk of a hazardous situation.

Device

Cook Aspiration Unit
  • Modelo / Serial
    Cook Aspiration Unit Part Numbers: K-MAR-5200, K-MAR-5200-USGlobal Product Numbers: G49275, G51067ARTG Number:156032(William A Cook Australia - Suction unit, electric powered)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd