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The Department of Health (DH) today (May 4) draws public's attention to 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.
A spokesman for DH remarked that the Department's Medical Device Control Office came to learn of the above recall through its surveillance scheme.
The spokesman then explained, "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," the spokesman said.
"DH understands that international regulatory authorities including UK's Medicines and Healthcare Products Regulatory Agency and US' Food and Drug Administration also find the proposed course of action acceptable."
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 www.defibtech.com/fa11 to see if their devices are affected.
"After risk assessment, DH also concurs that those who possess the affected products can keep their devices and contact their distributor or the US manufacturer for software upgrade. Further information on this issue can be obtained from Defibtech's website at www.defibtech.com/news/20110429.html," the spokesman stated.
DH will be monitoring the progress of the corrective action closely.
Ends/Wednesday, May 4, 2011
Issued at HKT 20:00
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