Defibrillation electrode SCHILLER DF87C and Defibrillation electrode SCHILLER DF56C 의 안전성 경고

Safety alert

2016-11-08

2016-11-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20161108.html

Medical device safety alert: leonhard lang defibrillation electrode schiller df87c and defibrillation electrode schiller df56c the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning defibrillation electrode schiller df87c and defibrillation electrode schiller df56c manufactured by leonhard lang. the affected reference number is 0-21-0040 for defibrillation electrode schiller df87c and 2.155065 for defibrillation electrode schiller df56c. during an investigation triggered by customer feedback, it was discovered that the use of the above mentioned defibrillation electrodes with the defibrillator defigard touch 7 may lead to a cable break. this cable break depends on the operating conditions and is caused by the repeated opening and closing of the device bag. investigations have shown that this defect may occur after more than 400 opening and closing cycles at the earliest under certain aggravated mechanical conditions. according to the manufacturer, there is a risk that the required treatment (ecg analysis or delivery of electric shocks) only can be realized after replacement of the electrode. this may cause a situation in which a patient, who is in a life-threatening condition and requires a defibrillation shock, cannot be treated in good time. the manufacturer advises users to disconnect the connector of current electrodes from the defigard touch 7, keep a second pouch of defibrillation electrodes available in the defigard touch 7 bag and not to preconnect these new electrodes. up to the disposal of spare electrodes the defibrillator defigard touch 7 can be used without restriction using not preconnected electrodes. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-31-october-4-november-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 november 2016.