Events

Retiro De Equipo (Recall) de IPAD Defib Pad, CU-CUA0512F (used with I-PAD NF 1200 Defibrillator)

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-2013-RN-00169-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-02-22
  • 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-00169-1
  • 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
    Discrepancy exists between the voice prompt of the i-pad nf 1200 defibrillator (version 7.0 only) and the physical pads currently supplied: a) the voice prompt says "remove the white and blue packet and tear open the package across the top and remove pads". please note the defibrillator pad packet supplied with the unit is white and orange, not white and blue. b) the voice prompt then says "... peel the pad completely from it's white backing".Please note that the backing is blue for some lot numbers supplied. note that both pads are compatible regardless of the backing colour.
  • Acción
    For problem a): In order to avoid any confusion during use of the I-PAD NF 1200 Defibrillator, Device Technologies is supplying blue labels that can be placed over the orange section of the current packet. This will ensure the packet colour matches the voice prompt. For problem b): Device technologies is advising that both pads are compatible regardless of the backing colour. Device Technologies will contact affceted customers when new pads are available to match the voice prompt.

Device

IPAD Defib Pad, CU-CUA0512F (used with I-PAD NF 1200 Defibrillator)

Manufacturer

Device Technologies Australia Pty Ltd