http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm

Defective Cardiac Science Corporation Powerheart and CardioVive Automated External Defibrillators: Initial Communication
Date: November 19, 2009
Audience: Users of certain Cardiac Science automatic external defibrillators
Medical Specialty: Cardiology

Device: Cardiac Science Powerheart and CardioVive Automated External Defibrillator(AED) G3 Series manufactured between August 2003 and August 2009. These devices are used for emergency treatment of victims with symptoms of sudden cardiac arrest who are unresponsive and not breathing.

Problem and Recommendations
Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected Cardiac Science Powerheart and CardioVive AEDs to follow these precautions:
If alternate AEDs are available, then use those AEDs until the Cardiac Science Corporation AEDs have been repaired or replaced, or consider obtaining another AED.
Contact the company immediately to arrange for repairs or replacements (in the U.S. at 425-402-2000 (press option 1) or outside of the U.S. at +44-161-926-0011; or email AED175@cardiacscience.com).

For Home Use and Public Access Defibrillation Programs: If an alternate AED is not available, FDA recommends using the Powerheart and CardioVive AEDs if needed, as the units may still be able to deliver the necessary therapy. The consequences of not attempting to defibrillate a patient outweigh the risk that these devices may fail.

For Hospitals, Ambulances, Clinical Settings and Emergency Transport Settings: If an alternate AED is not available, then FDA recommends that trained responders ( i.e., personnel certified in Advanced Cardiac Life Support), use manual defibrillators if they are available, or use the Powerheart and CardioVive AEDs if manual defibrillators are unavailable. The Powerheart and CardioVive units may still be able to deliver the necessary therapy.

Cardiac Science Corporation issued a press release (11/13/09) alerting users of its Powerheart and CardioVive AEDs to a malfunction with these devices. FDA believes that the company’s communication does not sufficiently describe the existing defect in the affected devices. FDA is also concerned that the company’s proposed actions do not adequately address the problem, and believes that additional precautions are warranted.

Affected models include the following:
Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
CardioVive 92531, 92532 , and 92533

300,000 Cardiac Science AEDs worldwide are potentially affected by this problem.

Background
Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices’ self-test may not detect the defect in advance of their use. The specific problems may include:

Interruption of electrocardiography (ECG) analysis that prevents shock delivery, Failure to recognize pad (electrode) placement during use, or Interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if an ECG analysis is successfully conducted.

The specific problem with these AEDs is that defects in certain electronic components may not be detected by the device’s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during a rescue attempt, which may prevent resuscitation of patients and lead to serious adverse health events or death. Normally, users should always check the status indicator on the front of the AED to see whether the device is rescue-ready (green light is displayed). However, visual inspection of a green light may not reveal defective or non-working components inside the AED.

In some complaints, the device’s self-test detected certain component failures prior to use. In other complaints, the failures were only detected during patient use when the device did not perform properly. The firm is planning on releasing a software update in May 2010 that they claim will detect all failures. FDA is conducting an evaluation of the firm’s actions to verify that the defects are permanently corrected.

FDA Activities
FDA is gathering more data about this situation to better understand its potential public health impact. As FDA learns more, we will make available any new information that might affect the use of these AED devices.

Reporting Problems
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect any electronic or mechanical problem(s) with an AED, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

To help us learn as much as possible about the adverse events or inability of an AED to deliver defibrillator therapy, please include the following information in your reports, if available:
Make, Model, and Serial number of the device The initial and final conditions of patient
Description of the device problem and sequence of events that occurred

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@cdrh.fda.gov or 800-638-2041.

This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about its ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.