FDA Update on AED

Cardiac Science Corp. Powerheart and CardioVive Automated External
Defibrillators: Initial Communication
Audience: Cardiology healthcare professionals, hospital risk managers,
biomedical engineering staff, emergency responders
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. 300,000 Cardiac Science
AEDs worldwide are potentially affected by this problem. The G3 Series
devices were manufactured between August 2003 and August 2009. Affected
models include the following:
Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and

CardioVive 92531, 92532 , and 9253
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
AEDs to follow the additional precautions provided in this
communication. FDA is gathering more data about this situation to better
understand its potential public health impact and will make available
any new information that might affect the use of these AED devices.
Prompt reporting of adverse events can help FDA identify and better
understand the risks associated with medical devices. FDA encourages
anyone who suspects any electronic or mechanical problem(s) with an AED
to file a voluntary report through MedWatch, the FDA Safety Information
and Adverse Event Reporting Program.
Read the complete MedWatch 2009 Safety summary, including a link to the
FDA Initial Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm


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