Initially intended to save lives, the defibrillator has in recent past been the cause of thousands of deaths. A defibrillator is a medical apparatus used to control the heartbeat by applying an electric current to the chest wall or directly to the heart. It is used to jumpstart the heart when it stops beating. Unfortunately, there have been tens of thousands of malfunctions that have resulted in either death or injury.

Since 2005, there have been over 45,000 reports of malfunctioning defibrillators according to the Food and Drug Administration. That is one in fifty of the more than two million defibrillators deployed in nearly every public place. With cardiac arrests being responsible for the deaths of over 400,000 people per year in the US, it is a very scary prospect to consider that these machines that are part of every emergency kit can fail to work.

So what causes these defibrillators to malfunction?  FDA officials reported that most malfunctions were the cause of manufacturing problems but there were some cases where the machines were simply not maintained well, like in cases of battery failure.

The devices have been called back at least 88 times since 2005 and now the FDA has decided to take a stand to strengthen defibrillator regulation. After all, 88 times is about 87 times too many for such a critical device.

It has therefore issued an order that will require manufacturers to submit the details of their designs and control measures used in purchasing the components to assemble a defibrillator. It would also require the manufacturers to have their companies inspected as part of the pre-market approval process.

These measures take effect from 2015 and many manufacturers are not excited about complying due to expected increase in the cost of production, which would result in reduced availability of the devices. To make things easier for manufacturers, the FDA has allowed them to seek only one pre-market approval for the entire range of defibrillators regardless of model, the logic being that the quality standard remains the same.

While these measures are still being put in place, you or your loved one could be at risk of being harmed or killed as a result of a malfunctioning defibrillator in the event of an emergency. As such, you should seek the services of a personal injury lawyer since the manufacturer is liable for the injury or death caused by the device malfunction.