Events

Retiro De Equipo (Recall) de Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-2013-RN-00467-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-17
  • 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-2013-RN-00467-1
  • 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
    The manufacturer found that if the headphone jack is in use during a surgical procedure with the ocs2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
  • Acción
    Integra is advising users that the device may still be used providing the audio jack is not used. An Integra representative will contact affected customers to arrange for the disabling of the audio jacks and prevent the problem occurring. No reports of this issue have been received from the field.

Device

Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)
  • Modelo / Serial
    Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)Catalogue number: OCS2All serial numbers affectedARTG number: 150717
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd