LIFEPAK CR Plus and LIFEPAK EXPRESS 의 안전성 경고

Safety alert

2013-03-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20130325.html

Safety alert on two automated external defibrillators the department of health (dh) today (march 22) drew the public's attention to a safety alert issued by an american medical device manufacturer, physio-control inc, on the battery performance of two of its automated external defibrillators (aeds), lifepak cr plus and lifepak express. the dh, through its routine surveillance on medical devices, noticed the above alert from the uk's medicines and healthcare products regulatory agency (mhra). according to the manufacturer, both aeds operate to deliver therapy by battery power. the battery charger is designed to be replaced approximately every two years. however, in some rare situations, the battery charger might experience early internal battery depletion due to an internal electrical failure, resulting in the battery charger lasting less than two years. devices manufactured from 2005 to 2012 are potentially affected by this issue. physio-control inc remarked that the probability of such a failure was extremely remote and the display of the aeds would continue to reflect the device and battery status, even if the device is affected by the issue. "locally, the dh's preliminary enquiries with the local supplier, ids medical systems (hong kong) company limited, revealed that lifepak cr plus has been distributed in hong kong. while the distribution of the potentially affected devices is being confirmed by the supplier, customers are advised to immediately check the readiness of their devices and the battery according to the operating instructions. they should contact their local supplier if a problem is identified. "so far, the dh has not received any relevant report of adverse incidents related to the aeds in hong kong," the spokesman added. the dh has informed public and private hospitals and relevant medical associations about the alert and shall continue to liaise with the supplier on the follow-up actions. ends.