Recall of Cardiac Science automated external defibrillators
(January 31, 2012)
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.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201201/31/P201201310519.htm
)
