Australian Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Corpatch Easy Pediatric (defibrillator electrodes), manufactured by Leonhard Lang GmbH. The affected product code is CP-5120.2 with 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
The manufacturer's 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.
Product replacement is on-going.
For details, please refer to the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00388-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 May 2015