One of the fastest-growing medical devices in use in the United States, implantable cardioverter defibrillators (IDCs) are implanted in the chests of heart patients to monitor and regulate heartbeat by generating electrical pulses. While IDCs are commonplace, with as many as 200,000 patients in the US estimated to have received one in 2005, they are complex devices and can malfunction for a variety of reasons. The average IDC lasts seven to ten years before needing to be replaced. However, depleted batteries and faulty memory chips have resulted in product recalls requiring patients to undergo more frequent replacement surgeries. Companies which have recalled IDCs include Guidant Corp., Medtronic Inc. and St. Jude Medical.
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.