Zoll Initiates Field Corrective Action on AED Plus
User-Installable Software Update Detects Battery-Aging Defect
April 2, 2009—CHELMSFORD, MASS.—ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of resuscitation devices and related software solutions, announced today it has initiated a voluntary worldwide field corrective action on its ZOLL AED Plus® automated external defibrillator. The Company has determined that some batteries do not work properly when used with AED Plus defibrillators manufactured prior to February 12, 2009 (serial numbers below X_ _ _200000). In addition, the version of the AED Plus self-test software installed in these devices does not adequately detect defective batteries. As a result of these two issues, the AED Plus defibrillator may fail to deliver defibrillation shocks during treatment of sudden cardiac arrest. The Company’s investigation is not complete at this time.
This corrective action applies to approximately 180,000 units. Devices installed for at least three years are at the highest risk, a population of approximately 80,000. Although this issue was identified through customer reports from non-clinical testing, there has been one clinical event reported in which a defibrillation shock was not delivered, the patient subsequently died, and an evaluation of the device found that the batteries experienced the identified problem. At this time ZOLL has reviewed all reported patient events and found up to three additional cases in which a shock was not delivered to a patient and the battery may have experienced the identified problem. The Company was informed that in one of the cases the patient subsequently died.
The required correction is available in the form of a software update, which can be easily downloaded from the company’s web site and installed by the user. This new software, which is included in current shipments of the AED Plus, can detect this battery defect condition if it occurs within the maximum five-year standby lifetime, and alert the user to install fresh batteries.
Working with its distributors, ZOLL began notifying customers with affected devices on February 12th, advising the immediate replacement of batteries on a three-year schedule until their device software can be updated. There is no need to remove devices from service pending the corrective action.
More information on this corrective action, including instructions for downloading software and ordering replacement batteries is available at http://www.zollaedplusbatteryhelp.com/ Customers can also call ZOLL Technical Support at 1 (800) 348-9011 or email Tservice_AED@zoll.com
Although the root cause investigation is not fully complete, it appears that high internal resistance can develop in some batteries after several years in standby mode. It is possible that this can lengthen charging time beyond specified and clinically acceptable limits, resulting in the failure of the AED Plus to deliver a defibrillation shock. It is difficult to predict which batteries may develop this condition, and the affected devices’ self-test does not detect this condition. The FDA has been notified of this problem and is expected to classify it as a recall.
This action does not apply to AED Plus devices manufactured after February 12, 2009 (serial numbers above X_ _ _200000), and the company does not expect any disruption in AED Plus supply or unusual backlog from this corrective action. Costs associated with notification and monitoring of customer implementation of this corrective action, and reporting compliance to appropriate regulatory authorities, will be accrued in the fiscal quarter ended March 29, 2009.
About ZOLL Medical Corporation
ZOLL Medical Corporation is committed to developing technologies that help advance the practice of resuscitation. With products for pacing, defibrillation, circulation, ventilation, and fluid resuscitation, ZOLL provides a comprehensive set of technologies, including Real CPR Help® and See-Thru CPR®, that help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims. ZOLL also designs and markets software that automates the documentation and management of both clinical and non-clinical information.
ZOLL markets and sells its products in more than 140 countries. The Company has direct operations, distributor networks, and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East and Africa, Asia, and Australia. During 2008 ZOLL marked the 25th anniversary of the company’s resuscitation product development. For more information, visit www.zoll.com.
Certain statements contained in this press release, including statements regarding the future business of the Company, and other statements contained herein regarding matters that are not historical facts, are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those factors discussed in the section entitled “Risk Factors” in the Company's Quarterly Report on Form 10-Q filed with the SEC on February 6, 2009. You should not place undue reliance on the forward-looking statements in this press release, and the Company disavows any obligation to update or supplement those statements in the event of any changes in the facts, circumstances, or expectations that underlie those statements.
Copyright © 2009 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. ZOLL, AED Pro, Real CPR Help, and See-Thru CPR are registered trademarks of ZOLL Medical Corporation.