FDA Safety Communication update for Zoll LifeVest 4000 wearable cardioverter defibrillator
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.”
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.
In January 2018, patients and healthcare 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.
Visit FDA to see recommendations for healthcare providers, patients, and caregivers.
