IN THE NEWS
Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction
PRNewswire-FirstCall via COMTEX News Network
BOTHELL, Wash., -- Cardiac Science Corporation is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.
Cardiac Science has received a total of 64 complaints concerning four resistors within certain AEDs. Two of these complaints were associated with a failure to deliver therapy. This issue is predicted to occur in approximately one in 75,000 AEDs manufactured between August 2003 and August 2009. The company has also received 114 complaints regarding "Service Required" messages resulting from a specific relay switch failure. There have been no reported instances where this issue has resulted in an inability to deliver therapy.
Until a correction is available in May, 2010, the company strongly advises customers to check the status indicator on the front of the AED and follow the procedures documented in the materials accompanying the AED. The company advises that customers leave their AEDs in service.
"When customers choose a product from Cardiac Science, they expect outstanding reliability," said Dave Marver, president and chief executive officer. "We understand the role our products play in public health and are taking appropriate measures to further improve the performance of our products."
The company has implemented more stringent testing of the components and all AEDs produced since August, 2009 are unaffected. Customers in possession of an AED that may exhibit either of these issues will be notified immediately. A software update to address the resistor issue will be available by May, 2010. This software update will enhance the AED's self-test capabilities and improve detection of the issue. In the interim, the company advises customers to keep their AEDs in service and follow the normal testing and maintenance procedures found in the Operator and Service Manual. A copy of these procedures is available at www.cardiacscience.com/AED175. At this site, customers may confirm if their AED is affected and register for automatic e-mail reminders to conduct scheduled maintenance.
If the AED is not rescue ready (the indicator is red) customers should contact the company immediately at 425.402.2000 (option 1) within the United States. Outside the US contact +44.161.926.0011 or the local Cardiac Science representative. Customers can also email the company at AED175@cardiacscience.com.
About Cardiac Science
Cardiac Science, a wholly owned subsidiary of Opto Circuits (India) Ltd., develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators (AED), electrocardiograph devices (ECG/EKG), cardiac stress treadmill and systems, PC-based diagnostic workstations, Holter monitoring systems, hospital defibrillators, vital signs monitors, cardiac rehabilitation telemetry systems, and cardiology data management systems (informatics) that connect with hospital information (HIS), electronic medical record (EMR), and other information systems. The company sells a variety of related products and consumables and provides a portfolio of training, maintenance, and support services. Cardiac Science, the successor to the cardiac businesses that established the trusted Burdick®, HeartCentrix®, Powerheart®, and Quinton® brands, is headquartered in Bothell, Washington. With customers in almost 100 countries worldwide, the company has operations in North America, Europe, and Asia. For information, call 425.402.2000 or visit http://www.cardiacscience.com.
This press release contains forward-looking statements. The words "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward-looking statements in this press release include, but are not limited to, those relating to Cardiac Science Corporation's future AED sales in Japan, expected shipments of backordered products in the fourth quarter of 2010, and expectations regarding the closing of the transaction with Opto Circuits. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks include those more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2009, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.
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