Users of the Zoll LifeVest 4000 contact Zoll immediately for a replacement if you see: “Call for Service—Message Code 102.”

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication

Date Issued

March 6, 2019

Audience:

• Patients with a Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
• Caregivers of patients with a Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
• Cardiologists, electrophysiologists, cardiac surgeons, primary care physicians, and allied health professionals treating patients with heart rhythm problems using a Zoll LifeVest 4000 Wearable Cardioverter Defibrillator

Medical Specialties:

Cardiac Electrophysiology, Cardiology, Cardiac Surgery

Device:

The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers an electrical shock to restore the patient to a normal heart rhythm. The LifeVest 4000 is the only wearable cardioverter defibrillator currently available in the United States.

Purpose:

The U.S. Food and Drug Administration (FDA) is reminding users of the Zoll LifeVest 4000 to contact the manufacturer immediately for a replacement device if their device displays the message: “Call for Service—Message Code 102.”

We are also providing updated information on safety concerns related to the Zoll LifeVest 4000. Zoll is in the process of implementing a software update to all Zoll LifeVest devices to increase the prominence and persistence of the “Message Code 102” alert on the device’s display screen to help users identify and replace devices that may have an electrical issue which results in the device failing to deliver a shock to a patient if needed.

Summary of Problem and Scope:

In January 2018, patients and health care providers were informed of a potential problem in the charging circuitry of the LifeVest 4000, which may prevent it from delivering a life-saving shock to patients wearing the device. As previously communicated by both the FDA and Zoll, users should contact Zoll immediately and replace the device after “Call for Service—Message Code 102” first appears on the device screen. Failure to take prompt action could result in serious patient harm or death because the device may not deliver the necessary electrical shock when needed.

On January 7, 2019, the FDA approved Zoll’s new software update for the LifeVest 4000 with a more prominent and persistent patient alert for “Call for service – Message Code 102” that instructs patients to call Zoll immediately at 1-800-543-3267 for a replacement LifeVest. Zoll will provide a replacement device as soon as possible, within 24 hours of receiving a call about a “Message Code 102”. On January 8, 2019, Zoll issued a letter to health care providers regarding this software update.

The FDA believes that the new, more prominent and persistent patient alert for “Message Code 102” will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen.

The FDA is reminding providers, patients, and caregivers of the importance of contacting Zoll immediately to replace the LifeVest 4000 after receiving a “Message Code 102.” To date, FDA is aware of two patient deaths due to the LifeVest's failure to deliver treatment as expected after Message Code 102 was displayed. The second death was reported to the FDA after Zoll issued its letter on January 8, 2019. However, both deaths occurred with devices that were in use prior to the new software update.

Recommendations for Health Care Providers:

• Continue to remind all LifeVest 4000 patients to respond to the “Call for service - Message Code 102” by contacting Zoll immediately. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week, at: 1-800-543-3267. The “Message Code 102” means that the LifeVest 4000 has a potentially serious service problem and the device may not deliver life-saving treatment if needed. Zoll will replace the patient’s device within 24 hours if the device displays “Message Code 102.”

Recommendations for Patients and Caregivers:

• Contact Zoll right away if the “Call for service – Message Code 102” alert appears on your LifeVest 4000 screen. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
• The “Call for service - Message Code 102” alert means that the LifeVest 4000 might have a serious problem and the device might not deliver a life-saving shock if needed.
• Zoll will replace your device within 24 hours, for free, if the device displays “Message Code 102.”
• Continue to use your LifeVest while you wait for the replacement. Even if the “Call for service – Message Code 102” alert appears, the device may still be able to deliver a life-saving shock to restore normal heart rhythm, if needed.

FDA Actions:

The FDA will continue to work with Zoll to monitor and identify a permanent solution to the “Message Code 102” issue. The FDA will provide additional updates when new information becomes available.

• The FDA first communicated about this issue in a January 17, 2018 Safety Communication. Patients and health care providers were informed that users should contact Zoll immediately and replace the device after “Call for Service - Message Code 102” appears on the device screen. Failure to take prompt action could result in serious patient harm or death because the device may not deliver a life-saving shock if needed. In addition to the FDA’s communication, Zoll issued a voluntary recall for the LifeVest 4000 on January 14, 2018, due to the potential for the device to not deliver treatment.
• In a July 25, 2018 updated safety communication, the FDA provided additional information to patients and health care providers regarding Zoll’s efforts to remedy the potential hazard of the LifeVest 4000 not delivering treatment to a patient through revised patient training and plans for a software design change.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks related to the use of medical devices. If you suspect or experience a problem with these devices, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.