Cardiac Science Corporation Notifies AED Customers of Nationwide Voluntary Medical Device Correction
Published: Feb 28, 2012
BOTHELL, Wash., Feb. 27, 2012 /PRNewswire/ -- Cardiac Science Corporation is initiating a voluntary field correction of a limited number of automated external defibrillators (AED) manufactured between July 1, 2011, and December 30, 2011. The affected AEDs contain a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver adequate defibrillation therapy. Failure of the component may affect resuscitation of the patient, which could lead to serious adverse events or death.
The affected models include Powerheart® 9300A, 9300E, 9300P, 9390A, and 9390E, and GE Responder® 2019198 and 2023440. In addition, certain CardioVive® 92532 and 92533 and Nihon Kohden 9200G and 9231 models serviced during this time are also affected.
This issue was detected at the Cardiac Science factory through the company's standard quality-control processes. There have been no reported instances where failure of this component has resulted in an inability to deliver therapy. The unit's self test may not detect the failure or impending failure of the component.
Customers in possession of an AED that is impacted by this issue were notified in January 2012. Customers with impacted devices should contact the company immediately at 1.888.402.2484 (in the United States), +1.425.402.2482 (outside the United States) or at firstname.lastname@example.org. Customers can view more information on this recall and specifics about product correction at www.cardiacscience.com/AED210. At this site, customers may also confirm if their AED is affected.
About Cardiac Science
Cardiac Science 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.
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SOURCE Cardiac Science Corporation