There are many different types of defibrillators. An
automated external defibrillator (AED) is a portable
electronic device that diagnoses and treats cardiac arrest
by re-establishing an effective heart rhythm. This
treatment is called defibrillation, which applies an
electric shock to the entire heart muscle, uniformly
clearing the electrical activity of the heart and hopefully
allowing it to resynchronize.
An AED is called external because the operator applies the
electrode pads to the bare chest of the victim, unlike
internal defibrillators, which have electrodes surgically
implanted inside the body of a patient. There are two main
types of AEDs on the market today: semi-automatic and
fully-automatic.
Semi-automatic AEDs prompt the user to stand clear and then
to push a shock button to defibrillate. Fully-automatic
units sound a stand clear voice prompt and then deliver the
shock automatically without the user having to push a
button.
AEDs can be found in corporate and governmental offices,
shopping centers, airports, restaurants, hotels, sports
stadiums, schools and universities, community centers, and
other places where large groups of people gather and the
risk of a sudden cardiac arrest incident is likely. In some
cities, all police vehicles carry an AED. All hospitals,
fire departments and health care professionals use AEDs to
address cardiac problems as well. These AEDs are
indispensable tools for the emergency medical personnel who
use them. Therefore it is extremely important that these
devices are reliable as they can often mean the difference
between life and death for thousands of people each year.
Access Cardio Systems, Inc. Emergency Defibrillator Failures
In 2005, the Food and Drug Administration (FDA) issues a
worldwide recall of Access Cardio Systems, Inc. emergency
defibrillators as they were found to have faulty components
that could prevent the device from delivering a proper
shock. It was identified that two problems could occur in
these defibrillators. Some of these defibrillators have a
catastrophic failure of the shock delivery circuit board
that prevents the delivery of additional shocks. Others
were shown to turn on unexpectedly, thus causing the
"on/off" switch to become inoperative, and the batteries to
run down. After this malfunction the device will no longer
defibrillate or operate correctly. Since the recalls Access
Cardio Systems, Inc., the manufacturer of these
defibrillators, went out of business. It is not possible to
replace any disposable parts for any of the machines that
were not found to be defective. The FDA has recalled many
of these defibrillators and has advised all Access Cardio
Systems, Inc. customers to immediately cease using the
devices and to find replacement devices elsewhere.
The FDA Recalls Access Cardio Systems, Inc. Emergency
Defibrillators
As part of the FDA's oversight of medical devices the
department has a classification system that includes three
classes of recalls, Class I, II, and III. Class I recalls
are the most serious type of recall and indicates that
there is a reasonable chance that the product will cause
serious health problems or death. The FDA has issued a
Class I recall of the following Access Cardio Systems, Inc.
devices:
. AccessAED PAD (without ECG trace) Public Access
Defibrillator (Model #9100-0010-0)
. AccessAED PAD Package (without ECG trace) (Model
#9100-0015-0)
. AccessAED Package (without audio record) (Model
#9100-0150-0)
. AccessAED (without audio record) (Model #9100-0100-0)
. AccessAED (with audio record) (Model #9100-0100-1)
. AccessALS (Advanced Life Support) (Model #9100-0100-2)
. AccessAED Package (with audio record) (Model #9100-0150-1)
. AccessALS Package (Model #9100-0150-2) . In a Class II
recall, there is a possibility that the medical device will
cause temporary or reversible health problems, or there is
a remote chance that the device may cause serious health
problems.
The FDA also issued the following Class II recalls of the
Access AED and Access ALS Automated External Defibrillators
(Model #9100-0100). Individuals who have experienced health
problems or injury related to these devices should seek
legal advice as they may be able to receive monetary
benefits. At this time the company is not offering any
refunds to those organizations that purchased the faulty
devices.
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