In November 2007, Anna Malofiy awoke in her Southampton, Pa., home to find her husband, Eugene, shaking and unresponsive. She called 911 and attempted cardiopulmonary resuscitation. A few minutes later, a police officer arrived with an automated external defibrillator (AED), the Powerheart model, made by Cardiac Science Corp. By administering an electric shock, such devices can save your life if your heart stops beating.
When the officer turned on the device, Anna’s lawyers claim, it displayed an error message and failed to operate. Officers and paramedics attempted to save Eugene Malofiy without the device but were ultimately unsuccessful.
Eugene’s nephew, Francis Malofiy, a lawyer practicing in Philadelphia, is suing Cardiac Science, based in Bothell, Wash., for construction and design defects, a failure to warn consumers about the problems, breach of contracts, and negligence. A jury trial is scheduled for July 2012.
“We went deep into police records and found a smoking gun,” Malofiy says. “Cardiac Science had 114 complaints of these specific relay-switch failures but failed to do any real corrective action. Rather than a recall being issued, rather than anything happening, the situation had to present itself many, many times.”
Cardiac Science did eventually recall about 280 000 of the Powerheart and other models. This is only one of many failures reported of AEDs, first-aid devices that have become increasingly common in the public spaces of the United States, where they are designated by the symbol of a heart and a lightning bolt. There are now 1.5 million AEDs deployed nationwide, five for each of the 300 000 people in the country who need them every year.
When a policeman, shopkeeper, or passerby uses an AED promptly and correctly, it can help keep the suffering person alive until professionals can provide treatment, increasing survival chances up to tenfold. Yet despite the enormous investment in these AEDs, the death rate from sudden cardiac arrest is no better than it was 20 years ago. It still kills more Americans than lung, breast, and prostate cancers and AIDS combined. Worldwide, it kills about 7 million people a year.
So what’s going wrong? Are too many AEDs badly designed or prone to malfunction? Are they just not numerous enough to be found and used in time? Or are there other reasons they aren’t saving lives, reasons that would render public AEDs a waste of money?
First, a primer on the problem. Sudden cardiac arrest is not a heart attack. In a heart attack, blood can’t flow properly to the heart but the muscle itself keeps beating, so sufferers typically remain conscious. In cardiac arrest, the heart’s pumping mechanism—an electrochemically choreographed affair—becomes deranged, so that the many motions of the various parts no longer work together to pump any blood. With no blood flowing to the lungs or brain, victims rapidly lose consciousness.
From that moment on, time is of the essence. For every minute that passes without a heartbeat, the patient’s chance of survival drops by up to 10 percent. Even if a properly trained bystander immediately starts cardiopulmonary resuscitation (CPR), rapidly compressing the patient’s chest to force blood around the body, survival rates will still decline 5 percent per minute. To actually save the person, you must restore the heart’s normal sinus rhythm, and this is where AEDs come in.
Sudden cardiac arrest is most often caused by ventricular fibrillation, when the heart’s lower chambers stop beating and instead quiver rapidly and irregularly. AEDs detect this distinctive quivering and then deliver one or more electric shocks. The shocks cause the heart’s muscle cells to contract simultaneously, interrupting the disorganized spasms and, if all goes well, rebooting the malfunctioning organ.