FDA Updates Safety Alert on Zoll LifeVest

FDA has updated a 1/18 safety alert that warned health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that it may fail to deliver treatment if it is not replaced soon after displaying a “call for service” message code 102. Failure to contact Zoll and immediately replace the device after the message code appears may result in serious patient harm or death, the alert said at the time.

The update says Zoll is planning to implement a software design change that will display a new, more prominent and persistent message scheme for Code 102. The proposed change needs to be submitted to FDA for review and approval. Additionally, the company has implemented a WEAR Checklist during patient fitting and training to reinforce instructions about how to wear the device, when to change the battery, and how to respond to siren alerts and gong alerts.