Skintact DF32L and DF31L Defibrillation Electrodes for Children 의 안전성 경고

Safety alert

2014-12-02

2014-12-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141202b.html

Medical device safety alert: leonhard lang skintact df32l and df31l defibrillation electrodes for children the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning skintact df32l and df31l defibrillation electrodes for children manufactured by leonhard lang gmbh. below are the details of the affected products: 50018 skintact df32l with lot number 30513-0770 59945 skintact df31l with lot numbers 30425-0778 and 30516-0770 during an internal investigation triggered by market feedback, it was discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. this potential malfunction can occur with electrodes after a duration of storage of about 2 years or more. the precise cause of this is still under investigation. as this potential malfunction could lead to a lack of, or delay in, providing therapy with potentially serious consequences including death and serious injury, the manufacturer is recalling all lots of these electrodes older than 18 months. other electrodes which show a faultless performance can be used as usual according to the instructions for use. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con477294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 december 2014.