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.
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