Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532 and 92533; and CardioLife 9200G and 9231 의 안전성 경고

Safety alert

2012-01-31

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20120201.html

Recall of cardiac science automated external defibrillators the department of health (dh) today (january 31) endorsed a local medical device supplier, pacific medical systems ltd's recall of a certain number of automated external defibrillators (aeds) made by a us manufacturer, cardiac science corporation, due to a possible failure in their delivery of defibrillation therapy. in fact, the recall is first initiated by cardiac science corporation in the us after it has detected through routine quality control that certain of its aeds made between july 1 and december 30, 2011 may not be able to perform. no report of rescue being impacted has been received anywhere in the world thus far. "according to cardiac science corporation, the affected models are powerheart 9300a, 9300e, 9300p, 9390a, and 9390e; cardiovive 92532 and 92533; and cardiolife 9200g and 9231," a dh spokesman quoted. "investigation by cardiac science corporation thus far reveals that the failure is likely due to a defect in a component of the circuit board which is amendable to corrective actions in the factory," the spokesman explained. pacific medical systems ltd reported that its sales record shows that they have imported some 135 involved devices into hong kong for supply to various users including dh. it will get in touch with affected customers to facilitate the return of the aeds for correction. in addition, the supplier has also set up a phone hotline at 2108 4005 for enquiries. "for the occasional customers who may have one of cardiac science corporation's aeds in hand and are uncertain about their status, they can visit the manufacturer's website at www.Cardiacscience.Com/aed210 to check by keying in the serial number marked at the back of individual devices," the spokesman elaborated. dh will be monitoring both the recall and in particular, the corrective action to be taken by pacific medical systems ltd. ends.