Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532 and 92533 의 안전성 경고

Safety alert

2009-11-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20091119.html

Field correction of automated external defibrillators the department of health (dh) today (november 18) alerted the public of a voluntary field correction by the manufacturer and supplier of two series of automated external defibrillator (aed)which may fail to deliver therapy during a resuscitation attempt. the affected models are powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, and cardiovive 92531, 92532 and 92533. the manufacturer, cardiac science corporation, estimated that one in 75,000 aeds manufactured between august 2003 and august 2009 may suffer the failure. a software update will be available by may 2010 to fix the problem. the company advises users to keep their aeds in service and follow the normal testing and maintenance procedures. about 262 aed of the two series of models have been sold to 157 users in hong kong. the local sole supplier of the affected aed, pacific medical systems ltd, could be contacted at 2108 4005 for advice. “users should follow the recommendations of the manufacturer and make contingency provisions in case the aed could not deliver therapy,” a spokesman for the department said. “the department had alerted the hospital authority, private hospitals, nursing homes, relevant institutions and medical association of the voluntary field action. “so far, no reports on adverse events arising from this issue have been received. “the department will closely monitor this field correction,” he said. ends/wednesday, november 18, 2009.