Corpatch Easy Paediatric (defibrillator electrodes) 의 리콜

Recall

RC-2015-RN-00388-1

Class I

2015-05-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00388-1

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.

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.