FDA Updates Safety Communication 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.”
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.”
Follow the link below to read the FDA’s update in detail, include recommendations for patients and caregivers.
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