Corpatch Easy Pediatric 의 안전성 경고

Safety alert

2015-05-11

2015-05-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150511a.html

Medical device safety alert: leonhard lang corpatch easy pediatric 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.