Events

Recall of Corpatch Easy Paediatric (defibrillator electrodes)

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-2015-RN-00388-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00388-1
  • 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
    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.
  • Action
    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)
  • Model / 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