Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00169-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00169-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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