defibrillation electrodes (model number PN9131-001) of lot number 141125-02 used in Powerheart G3 9300A, 9300E, 9300P, 9390A and 9390E Automatic External Defibrillators (AEDs) 의 안전성 경고

Safety alert

2015-12-31

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151231.html

Medical device safety alert: safety alert on cardiac science defibrillation electrodes (with photo) the department of health (dh) today (december 31) drew the public's attention to a safety alert issued by cardiac science corporation concerning its defibrillation electrodes (model number pn9131-001) of lot number 141125-02 used in powerheart g3 9300a, 9300e, 9300p, 9390a and 9390e automatic external defibrillators (aeds), as they may exhibit higher than expected electrical impedance over time. the dh, through its routine surveillance on medical device safety alerts, noticed the above alert from the medicines and healthcare products regulatory agency of the united kingdom. according to the alert, the affected lot of defibrillation electrodes was shipped to customers from december 26, 2014, to march 10, 2015, and the expiration date of the electrodes is june 12, 2017. cardiac science said that if electrode impedance becomes too high, the powerheart g3 aed will fail the electrode self-test performed by the aed and it will not be available for use in a rescue. when the electrode self-test is failed, the status indicator on the aed will be red and the aed will beep. in order to return the aed to its rescue ready state, the high-impedance electrodes require replacement. the manufacturer advises users to examine the electrodes currently installed in their aeds and in their inventory. the affected electrodes should be replaced, even if they are in an aed and the status indicator is green. according to the local supplier, pacific medical systems ltd, the affected lot of electrodes has been distributed in hong kong and they will get in touch with affected customers and arrange for product replacement. the dh's enquiries with the supplier revealed that 62 units of the affected lot of defibrillation electrodes have been distributed to clinics, schools and other venues. "so far, the dh has not received any relevant reports of adverse incidents related to the affected electrodes in hong kong," a dh spokesman said. the local supplier has set up a customer service hotline, 2571 7090, to answer related enquiries. the dh has informed public and private hospitals and relevant associations about the alert and shall continue to liaise with the supplier on the follow-up actions. ends/thursday, december 31, 2015 issued at hkt 19:50.