The FDA sent out a notice on Tuesday regarding external Cardiac Science of Bothell defibrillators, telling healthcare and “high-risk” facilities to use alternatives because the devices can malfunction during a time of need.
The problem lies in faulty components which may cause the device to “fail to properly deliver a shock.” Additional problems include: “interruption of electrocardiography analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.”
Considering these devices are used to address sudden cardiac arrest (a condition where the heart stops beating), the risk of malfunction is one not worth taking.
Home users and public facilities who own the device or keep the device at hand and are of lower risk should replace their defibrillators in the long run, but can continue using the Cardiac Science models until replacements can be obtained.
This comes after Cardiac Science’s February announcement that an FDA inspection found that the company wasn’t meeting FDA requirements, recalling 12,000 defibrillators at that time.