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Defective Automated External Defibrillators Recall, Medical Device Negligence
What could be worse than a false sense of security during a heart resuscitation attempt? Is this medical device negligence?
Earlier this year Cardiac Science Corporation and Food & Drug Administration notified healthcare professionals and consumers of an AED recall because the life saving device may not be able to deliver therapy during a cardiac resuscitation attempt.
An AED is a small, portable device that can send an electric shock through the chest wall to the heart and restore a patient’s heart rhythm to normal levels before emergency crews arrive on the scene.
The Cardiac Science Corporation’s AED failure problem is caused by how the life saving heart devices are manufactured.
Approximately 12,200 AEDs were affected by the worldwide recall. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Cardiac Science detected this issue through its internal quality systems.
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In April 2010 Cardiac Science Corporation updated its FDA alert to include Nihon Kohden (NK) and GE Responder models which were not previously identified in earlier communications about this recall.
Additionally, Cardiac Science Corporation issued a software upgrade for the devices’ self tests on 02/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects.
Affected AEDs were manufactured and distributed between August 2003 and August 2009.
Have you or your family have been the victim of a defective AED manufactured by Cardiac Science Corporation? If the answer is yes – take action today by contacting Monheit Law to find out what your legal recourse is. Medical device negligence is serious business.
