The Department of Health (DH) has drawn public attention to performance defects in two brands of automated external defibrillators (AEDs), MEDUCORE Easy and LIFEPAK 500, made respectively by two medical device manufacturers, Weinmann and Medtronic, because of potential malfunctions in both.
The two incidents came to DH's notice through its surveillance system on medical device mishaps. Both devices are designed for use during cardiopulmonary resuscitation.
According to Weinmann, the time allotted for charging the capacitor in MEDUCORE Easy is insufficient for a full charge and hence may result in device failure. The incomplete charging can be eliminated through a modification to the firmware and Weinmann urges customers to send their devices to their local suppliers for upgrading.
The second incident involves LIFEPAK 500 AED, created by Physio Control, a division of Medtronic. It is noted that the electronic component on the main printed circuit board of a certain number of devices is susceptible to moisture, which could again cause malfunction as a result.
Physio Control remarked that two patients were reported as unable to be resuscitated. However, definitive causal conclusions still remained to be determined. Nevertheless, the company is advising customers to contact their local service personnel for their follow-up.
DH's preliminary inquiries on the two manufacturers, including their local suppliers, revealed that while no MEDUCORE Easy device has been supplied to Hong Kong, two LIFEPAK 500 AEDs are available locally. Both are only for use in demonstrations and thus not meant for sale.
"Despite the above, the possibility of possession of the above devices by individual customers cannot be ruled out and given the dreaded potential consequence of failed resuscitation, the DH opts that a public announcement is warranted as a matter of prudence," a DH spokesman explained.
So far, DH has not received any report of adverse incidents related to the two brands of AEDs in Hong Kong.
"Anyone who has the AEDs in question should take note of the announcement and act according to the corrective actions suggested by the manufacturers as soon as possible," the spokesman reminded the public.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201106/23/P201106230355.htm )