Cardiac Science Corporation (CSC), a company that makes medical devices and supplies for heart health, is recalling several models of external defibrillator. They are the Nihon Kohden and GE Responder automatic and semi-automatic models and they have been found to have defective components.
In a November 2009 recall, CSC issued a press release warning about other models called the Powerheart and CardioVive, which were also found to have faulty components. That recall is now being expanded.
The defibrillators being recalled now could possibly fail to deliver a shock when one is needed, and since timing is critical for a heart patient, that failure could be fatal. It could arise either from background noise preventing an accurate analysis of a person’s heart rhythm or from the unit having interrupted ECG (ElectroCardioGraph) analysis that blocks a shock delivery.
These defibrillators are external, as opposed to the internal implanted defibrillators or pacemakers that were recalled during 2009 by Boston Scientific and Medtronic.
A Class I Recall
CSC has been doing a field correction since November, but the FDA has now classified this as a Class I recall. Their announcement is dated yesterday and gives current details. Please see The Role of the FDA in Drug Recalls for more about that topic. They advise that high-risk and frequent-use facilities should either obtain another type of external defibrillator, or arrange for immediate repairs to their existing CSC defibrillators.
For public access defibrillation programs or home users, the FDA advises that an alternate defibrillator should be used while the CSC unit is being repaired; or if an alternate unit is not available, the old one may be used. They do deliver needed shocks most of the time and there would be greater risk in not doing any defibrillation than there would be in using a CSC unit.
The full name for these units is Cardiac Science Corporation Automated External Defibrillators and the model numbers can be found on the back of each unit.
Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
CardioVive 92531, 92532, 92533
NK 9200G, 9231
Responder 2019198 and 2023440
CSC will be providing a software upgrade to improve each unit’s ability to detect a device failure.
When a defective product has been marketed and has injured people or caused deaths, a product liability lawsuit can be filed. If you have been hurt by a faulty product and would like to know more about your legal position and options, please contact us today for a free case evaluation. We serve the residents of Mobile Alabama and will be pleased to welcome you to our office.