Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00169-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00169-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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