![]() DH will be monitoring the progress of the corrective action closely. Further information on this issue can be obtained from Defibtech's website at the spokesman stated. The DDU-2000 Series AED is a Semi-Automatic External Defibrillator that is designed to be easy to use, portable, and battery powered. "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. Customers can check the nine-digit serial number on the back of the AEDs against the list published by Defibtech at to see if their devices are affected. "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. The latter can be performed at the location where the devices are deployed," the spokesman said. "Therefore, Defibtech recommends that customers can keep their devices in service until the Company has performed the software upgrade. 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. Moreover, the defect is not detectable by periodic self-test. The spokesman then explained, "The defect may result in the defibrillators unable to provide therapy which may mean failure to resuscitate patients. 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 defibrillators are sold under the brand names of Lifeline AED, ReviveR AED and Lifeforce AED. Corrective action involves software upgrading. 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. ![]() Each battery pack includes a new DAC-410 9-volt lithium battery. ![]() Alert on voluntary recall and corrective action by Defibtech on semi-automatic external defibrillators This replacement battery pack (DBP-2800) has a standby life (installed in the unit) of 7 years (including daily, weekly, monthly, and quarterly self-tests), 300 defibrillation shocks, or 16 hours of continuous opearting time. ![]()
0 Comments
Leave a Reply. |