Cardiac Science Corp. has voluntarily initiated a field correction of a limited number of automated external defibrillators (AED) manufactured between July 1 and Dec. 30 last year. The affected AEDs contain a component that may fail unexpectedly due to a supplier manufacturing defect, according to Cardiac Science.
Executives from the Bothell, Wash.-based device company claim that 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 also are affected.
Cardiac Science officials noted that the defect was noticed in their 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, however, the unit's self test may not detect the failure or impending failure of the component.
Cardiac Science Says Supplier Error Caused Recall
Published March 1, 2012
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