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Attorney Ronald E. Johnson of Schachter & Hendy concentrates on legal issues regarding defective medical devices. According to the Consumer Product Safety Commission, the ZOLL AED Plus Defibrillator was recently recalled because it was defective. The medical device was manufactured by ZOLL Medical Corporation from May 2004 through February 2009 and distributed from May 2004 through February 9, 2009. It is possible that between 80,000 to 180,000 units are affected.
The ZOLL AED Plus Defibrillator is used by emergency or medical personnel and others who have completed CPR AED training courses. The medical device is intended to treat patients who are undergoing cardiac arrest. It analyzes an unconscious person’s heart rhythm and delivers an electrical shock to the heart to restore a normal heart rhythm.
This device is affected by a Class 1 recall — the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. The defibrillator was recalled because the AED failed to deliver the defibrillation energy. Some batteries do not work properly when used with the ZOLL AED Plus Defibrillator below the units below the serial number X_ _ _200000. The serial numbers above X___20000 are not affected by this corrective action as they contain the updated software that can detect this battery condition and identify when batteries require replacement.
The ZOLL Medical Corporation informed rescue workers that in the event that the AED Plus fails to work, they should immediately resume CPR, and retry the ADI Plus after switching it off and then on again after 10 seconds so the device can reset.
According to a letter sent to consumers by ZOLL, they recommend an update of the device software. The new software can be ordered or downloaded at no cost at https://www.ZOLLAEDPlusbatteryhelp.com. The website also provides other technical information and support concerning this corrective action, such as ordering of replacement batteries. Consumers should use a Personal Computer running Windows XP or Windows 2000 that is equipped with an IrDA (infrared) port. Load the ZOLL Administrative Software (ZAS) onto your PC from either the ZOLL download site, or by ordering a CD from ZOLL. To do either, visit https://www.ZOLLAEDPlusbatteryhelp.com.
Consumers can contact the ZOLL Medical Corporation at:
269 Mill Road
Chelmsford, Massachusetts 01824
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
* Online: https://www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: https://www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* FAX: 1-800-FDA-0178