Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction

Cardiac Science Corporation [NASDAQ: CSCX] 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.

Forward-Looking Statements

This press release contains forward-looking statements. The word "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, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. 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 are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, 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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Emergency Physicians Reveal Strategies for Improving Sudden Cardiac Arrest Survival Rates in the U.S.

PRNewswire/ -- A new State of Resuscitation survey released today by the American College of Emergency Physicians (ACEP) finds an overwhelming majority (90 percent) of the emergency physicians surveyed believe that resuscitation practices in the United States are not very effective. Emergency physicians cite increased bystander CPR, faster patient-to-doctor time, improved data collection and sharing, and greater use of technology as critical to improving resuscitation for victims of sudden cardiac arrest (SCA).

"While we've made significant advances to improve resuscitation efforts, more needs to be done. The State of Resuscitation survey offers valuable insights on how we can build upon already existing practices, including increasing public involvement and implementing technology to help save more lives," said Dr. Nick Jouriles, president of ACEP. "The results clearly show that it is necessary for communities to encourage more CPR trainings, offer more access to a broader range of critical life-saving technologies, and report sudden cardiac arrest cases more consistently."

The survey shows that 9 out of 10 respondents (88 percent) consider bystander intervention an important factor to increase survival. Other factors viewed as having a positive impact on survival rates include faster patient-to-doctor time (77 percent), data collection and sharing (73 percent), automated technologies (66 percent), and real-time feedback on compressions (65 percent).

"The optimal treatment of patients who suffer out-of-hospital cardiac arrest requires a well-coordinated system of community members, emergency medical services (EMS), emergency department, cardiology and critical care services," said Arthur B. Sanders, M.D., professor of emergency medicine at University of Arizona Health Sciences Center. "Community programs include early access to the EMS system and training citizens in CPR. Over the past decade there have been important advances in the science of resuscitation. Unfortunately, implementation of the scientific advances has lagged in many communities. This survey reinforces the need to provide more education about CPR including the teaching of hands-only CPR. It also highlights the need for communities to monitor their survival data and implement changes that can improve all aspects of the system of care that can result in improved survival from SCA."

Survey Findings

Conducted in September 2008, the State of Resuscitation survey suggests that almost all emergency physicians (94 percent) believe that a patient in sudden cardiac arrest is more likely to survive if a CPR-trained bystander administers CPR before professional rescuers arrive. In addition, more than half believe the length of time between patient collapse and first responder arrival is an important factor in determining the success of resuscitation efforts.

The survey also suggests that an overwhelming majority (89 percent) of emergency physicians feel that technology will play an increasingly important role in resuscitation over the next five years. Eighty-four percent note that emerging technologies/therapies are important in treating sudden cardiac arrest. Only one in four considers automated chest compression devices important, despite research that indicates their positive impact.

Other important findings include:

-- Approximately 3 out of 10 respondents say CPR feedback devices would
have the greatest impact on improving the quality of CPR.

-- More than half the respondents believe that poor survival rates from
sudden cardiac arrest is related to the aging population, while
one-quarter of respondents believe that obesity has contributed most
to poor survival rates.

-- Efforts to teach citizens CPR are scattered, and often, non-existent.
Not surprisingly, the respondents want civic leaders to be more
engaged in this issue.


The online survey was commissioned by ACEP and conducted by Saperstein Associates, Inc., an independent opinion research company. ZOLL Medical Corporation sponsored the survey. A total of 1,056 questionnaires were completed by ACEP members in selected membership sections. The study has a margin of error no greater than +/- 3.1 percentage points at the 95 percent level of confidence.

ACEP is a national medical specialty society representing emergency medicine with more than 27,000 members. ACEP is committed to advancing emergency care through continuing education, research and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies.

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