Zoll AED Plus Defibrillators Recalled After Reports of Death
Zoll Medical Corporation recalled its AED Plus Defibrillators because of battery defects in some of the units, and malfunction of self testing software that fails to detect faulty batteries. Approximately, 180,000 units have been included in the recall.
The company sent a letter to customers in February warning them that the defibrillators were prone to a malfunction that has already been linked to the deaths of two people.
The Zoll AED Plus Defibrillator is used by emergency personal, medical personnel, and those who have received CPR AED training. The device is used to treat patients having a cardiac arrest. It works by analyzing the heartbeat of an unconscious patient and instructing the user to press a button that can deliver an electrical shock to the heart, and restore a normal cardiac rhythm. The recalled defibrillators failed to deliver an electrical shock to patients' heart.
In the letter it sent to customers in February, the company asked customers to get their batteries replaced every three years. In March, the company sent a follow up letter asking customers to download new testing software to test the devices. According to that letter, the defibrillators could be prone to failure because of defective battery test software that does not detect flawed batteries.
The recalled devices were manufactured from May 2004 to February 2009, and distributed during the same period. The company asked customers not to stop at changing the batteries, as that will not correct the problem, also, the device software must be downloaded for the defect to be corrected. The company also confirmed that it received two reports of death from the failure of the device. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall, meaning there is a ‘’reasonable probability’’ that using the product could cause injury or death.
Medical Injury Attorney
Complex medical devices like defibrillators have been responsible for saving thousands of lives, but when these are sent out into the market with a defect, the resulting injuries can be extremely serious. Medical injury lawyers can help victims, who have been injured because of these defects, recover compensation.
If you have been injured by the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.
Boston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations: