In short
Cardiac Science Corporation is initiating what it is calling 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.
Background
Headquartered in Bothell, Washington, just north of Seattle, Cardiac Science, an Opto Cardiac Care Ltd. company also has operations in California, Wisconsin, China, Central Europe, Denmark, France, and the United Kingdom. Cardiac Science develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators.
During the company’s standard quality-control processes a supplied component manufacturing defect was identified which has the potential to cause the defibrillator to fail to deliver adequate defibrillation therapy, although there have been no reported instances where failure of this component has resulted in this eventuality. The unit’s self test may not detect the failure or impending failure of the component.
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.
What to do
The company notified 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 aed210@cardiacscience.com. 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.
Source: Cardiac Science