Events

Retiro De Equipo (Recall) de Corpatch Easy Paediatric (defibrillator electrodes)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2015-RN-00388-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-07
  • 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-2015-RN-00388-1
  • 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
    An internal investigation showed that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this malfunction can occur with defibrillation electrodes that are older than 2 years. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. the precise cause for this is still under investigation. the electrodes are being in used in connection with the defibrillators corpuls 08/16, corpuls1 and corpuls3. other defibrillation electrodes manufactured for the corpuls defibrillators are not affected by the problem.
  • Acción
    Device Technologies Australia (DTA) is requesting their customers to isolate the affected electrodes. DTA is contacting the customers with a Good Return Authorisation (GRA) number and arrange collection. Replacement paediatric leads are available and will be provided as soon as possible. In the interim, if no paediatric defibrillation electrodes are available, DTS advises that standard adult electrodes may be used for defibrillation of patients <25kg. This action has been closed-out on 08/08/2016.

Device

Corpatch Easy Paediatric (defibrillator electrodes)
  • Modelo / Serial
    Corpatch Easy Paediatric (defibrillator electrodes)Product Code CP-5120.2 Lot Numbers: 30708-0777, 30822-0778, 31009-0773, 31121-0774, 40107-0771, 40213-0774, 40222-0773, 40320-0770, 40321-0770, 40324-0773, 40522-0779, 40704-0776, 40808-0773, 40923-0776, 41021-0778.ARTG number: 200520
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd