The Cochran Firm Legal Blog

ZOLL Medical Corporation has recalled its Automated External (AED) Plus Defibrillator in a Class I recall. This type of recall is used for defective medical devices which could cause severe injury or death if they continue to be used.

Atrial fibrillation is a very fast heartbeat that does not effectively pump blood around the body. A defibrillator is a device that monitors a cardiac patient’s heart rhythm, and sends an electrical shock to the heart if it goes into atrial fibrillation. The shock jolts the heart’s electrical system and restores it to a normal rhythm. Some defibrillators are implanted in the patient’s chest and some are external.

The ZOLL AED Plus™ Defibrillator
This defibrillator is an external one used by emergency response teams or medical workers with CPR training (Cardio-Pulmonary Resuscitation). It is designed for patients in cardiac arrest, meaning that their heart has stopped beating. Not all patients in cardiac arrest need a shock. About half will need it and the other half need CPR resuscitation.

The ZOLL AED has a graphical interface with text displays and voice prompts that walk a rescuer through each step in the right sequence. It can register what the rescuer is doing to help the patient, and will give messages to help make treatment more effective. For example:

• If the rescue worker is not pressing on the patient’s chest hard enough, it will give a message to push harder
• If the worker is pushing hard enough, it will say “Good compressions”
• If the chest compressions are not fast enough, a metronome will beat at the correct rate
• If the rescue work has not started yet, it will tell the worker when to start

This AED analyzes the patient’s heart electricity and if a shock is required, it directs the rescue worker to press a button that will deliver the electrical shock.

ZOLL AED Has Failed to Deliver the Electric Shock
By not delivering a required shock to the heart, this otherwise ingenious and helpful machine could endanger a patient’s life. In February, 2009, ZOLL sent an initial recall letter by certified mail to all its customers, reminding them to replace the device’s batteries every three years.

In March, 2009, ZOLL send a follow-up recall letter asking customers to download updated software for the defibrillator. It also sent this via email if it had an email address for the customer. ZOLL also plans to publish recall information in industry magazines. You can read more about ZOLL’s corrective actions on their Customer Support website page.

The FDA has extensive testing protocols and procedures in place for determining when a new product can be approved for marketing to the U.S. public. Sometimes an approved medical device or drug turns out to have a defect – whether in its functioning in all circumstances or in its labeling and warnings. A defective drug can be just as injurious as a defective medical device.

If you have been injured by a defective medical device, you may have a valid legal claim. To learn more, please contact our product liability lawyers today to schedule a free consultation and case evaluation.

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