Zoll LifeVest Lawsuit
The Zoll LifeVest 4000 Wearable Cardioverter Defibrillator (WCD), is a wearable defibrillator that is used to treat sudden cardiac arrest. Many patients required to wear a Zoll LifeVest 4000 Wearable Cardioverter Defibrillator, report complaints about the device.
“I left the hospital with a Zoll LifeVest,” says a member of the American Heart Association’s Support Network, “which I hate beyond measure.” Another describes the vest as “annoyingly bulky and heavy,” while a third notes that the wires between the ports on the vest “are too long and curl up and make the vest uncomfortable.” As it turns out, however, these may be the least serious problems linked to this device.
The Zoll LifeVest 4000 Wearable Cardioverter Defibrillator was designed to be a life-saving device for those at risk for sudden cardiac arrest and was supposed to give patients and their families some peace of mind.
In January 2018, however, the FDA announced a Class II device recall for the LifeVest because, under certain circumstances, it may not be able to deliver the life-saving shock as needed “due to a fault that prevents the device from charging its high-energy capacitors”. This puts patients at risk of a heart attack and death.
Thousands of families rely on these devices to protect their loved ones. Those who suffered damages because the device didn’t work as expected may be eligible to file a Zoll LifeVest Wearable Defibrillator lawsuit to seek compensation.
What is the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator?
The FDA first approved the Zoll LifeVest back in 2001. At that time, it was the 2000 model. Since then, there have been a number of upgrades, including models 3000, 3100, and today, the 4000, which the company says is smaller and lighter than past models. It is designed to be worn outside the body rather than inside, and is an alternative to an implantable cardioverter defibrillator (ICD).
The original approval was for adults only. But in 2015, the company received FDA approval for use of the vest in treating pediatric patients, as well. The Zoll LifeVest monitors for signs of ventricular tachycardia or ventricular fibrillation
- Ventricular tachycardia: A fast but regular heart rhythm that starts in the lower part of the heart. It can lead to ventricular fibrillation.
- Ventricular fibrillation: A fast, irregular heart rhythm that causes the heart to quiver, rendering it unable to pump blood. Requires immediate emergency medical attention. Ventricular fibrillation is the most frequent cause of sudden cardiac death.
The cause of these types of abnormal heartbeats are not always known. The risk factors for them are known, and include:
- Heart damage because of a previous heart attack
- Congenital heart disease
- Other heart problems like cardiomyopathy
- Other types of irregular heartbeats (arrhythmias)
Doctors often recommend an ICD for patients at risk for sudden cardiac arrest, but some patients may not want to be implanted with a medical device. Others may not be good candidates for an implantable device. In these cases, doctors may recommend a Zoll LifeVest.
The device itself consists of the following two components:
- A lightweight garment or belt-like vest that contains non-adhesive electrodes that continuously monitor the heart’s rhythms.
- A monitor and alarm that the patient wears in a holster around the waist. This is a technological device that collects ECG data from the electrodes, and can send that data to the patient’s doctor.
If the device detects an abnormally fast or irregular heartbeat, it first begins an alarm sequence, which alerts the patient to the issue with audible, tactile, and visual alarms, and gives him or her time to stop the shock if desired. If the patient doesn’t respond, the device gives a verbal warning, and then releases a conductive gel from within the electrodes, and finally delivers a high-energy shock to stabilize the heart again.
The manufacturer, Zoll, states on its website that the LifeVest allows patients “to return to their common activities of daily living, while having the peace of mind they are protected from [sudden cardiac arrest].” The company also notes that it can be used following a heart attack, before or after bypass surgery or stent placement, and by those with cardiomyopathy or congestive heart failure.
What is the Problem with the Zoll LifeVest 4000 WCD?
Zoll originally alerted patients to a potential issue with the LifeVest in September 2017. It issued a patient safety alert notice on September 12th, stating that if a service warning appeared on the device, patients should call the company immediately for a replacement LifeVest.
Specifically, the “Call for service‑Message Code 102” “could mean that your LifeVest may not be able to deliver therapy if you need it,” according to the notice. The company promised a replacement within 24 hours for those patients who noticed this alert and called in.
The company didn’t recall the device until January 14, 2018, however. The recall affects over 33,000 units that could potentially fail. The FDA released an accompanying safety communication on January 17, 2018, explaining that during a self-check, the device may not be able to charge its high-energy capacitors, which prompts the “call for service” message. After the device sends this notice, it doesn’t specifically warn the patient that the device may no longer work. So the patient may see the “call for service‑Message Code 102”, but not understand the urgency of the situation.
The FDA has also reported that it is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after the Message 201 was displayed. It also advised that about 0.1 percent of the devices have so far displayed the Message Code 102.
Patients who notice this message on their devices are advised to call Zoll Customer Service immediately at 1-800-543-3267.
Types of Injuries Associated with the Zoll LifeVest WCD
The FDA maintains a searchable database, called the “Manufacturer and User Facility Device Experience” database (MAUDE), which contains reports of adverse events involving medical devices. If a manufacturer receives a report from patients or their doctors regarding a problem with its device, it is required to send the report to FDA as specified by regulations, which is then added to the database. Patients (or their doctors) who experience a problem or issue with a medical device may voluntarily report those issues to the FDA, and these reports are then added to the database.
There are a number of such reports of problems, malfunctions, and serious injuries in the MAUDE database linked to the Zoll LifeVest.
In 2016, for example, a patient reportedly passed away while wearing the vest in the hospital. A later analysis of the data showed that the vest had shocked him twice, but it had not managed to restore his heart rhythm to normal.
Another patient also reportedly passed away in the hospital while wearing the vest, after receiving 40 inappropriate shocks from the device.
Other reports indicate that patients found the device uncomfortable, with one reporting blisters that drove him to take the device off, after which he allegedly passed away.
The American Heart Association Support Forum also contains a number of messages from patients describing various issues with the vests.
One user, for example, reported that her father was fitted for a vest, and a week later had to be transported via ambulance because “the monitor was trying to initiate treatment.” Doctors later advised the family that “it was just the vest,” but the family still had to manage the medical bill. “The machine will cause more heart attacks and problems than save people if this is going to continue,” the forum member wrote.
Patients using a Zoll LifeVest may be at risk for the following injuries:
- Blisters and skin irritation
- Allergic reactions to the metal in the electrodes
- Inappropriate shock
- Cardiac arrest
Zoll LifeVest WCD Lawsuits
Patients prescribed a Zoll LifeVest WCD who then suffered from serious or life-threatening injuries, or families who lost a loved one because the vest didn’t work as expected, may be eligible to file a Zoll LifeVest WCD lawsuit. Chaffin Luhana is now investigating these cases, and invites you to contact us immediately at 1-888-480-1123.