Dear Doctor,
We would like to bring to your attention that the Department of Health (DH) alerted the public on 4 May 2011 concerning a voluntary recall and corrective action by Defibtech on its semi-automatic external defibrillators.
There is a worldwide voluntary recall by a US medical device manufacturer, Defibtech, regarding its DDU-100 series semi-automatic external defibrillators (AEDs) because in some instances, the shock is cancelled during the charging process. Corrective action involves software upgrading. The defibrillators are sold under the brand names of Lifeline AED, ReviveR AED and Lifeforce AED.
The defect may result in the defibrillators unable to provide therapy which may mean failure to resuscitate patients. Moreover, the defect is not detectable by periodic self-test. However, according to information provided by the manufacturer, the odds of the occurrence of the defect are very very rare.
So far, DH has not received any report of adverse incident arising from the defective devices. Therefore, Defibtech recommends that customers can keep their devices in service until the Company has performed the software upgrade. The latter can be performed at the location where the devices are deployed.
In Hong Kong, Defibtech's record indicated that 82 affected devices have been distributed here. Customers can check the nine-digit serial number on the back of the AEDs against the list published by Defibtech at http://www.defibtech.com/fall to see if their devices are affected. More information is also available on Defibtech's website: http://www.defibtech.com/news/20110429.html
The alert is available at http://www.dh.gov.hk/english/press/2011/110504-3.html and DH will be monitoring the progress of the corrective action closely.
Thank you for your attention.
Yours faithfully,
(Dr Addi CHAN)
for Director of Health
Medical Device Control Office, Department of Health, HKSAR Government