FDA Safety Communication for Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
In January 2018, the FDA issued a Safety Communication alerting patients and health care providers that the LifeVest 4000 manufactured by Zoll, may fail to deliver a life-saving shock to a patient if the device is not replaced soon after displaying the following message: "Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102."
Failure to contact Zoll immediately and replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver treatment if needed. Zoll issued a voluntary recall for the LifeVest 4000 on January 14, 2018 due to the potential for the device to not deliver treatment.
Since January, Zoll has updated FDA with information on their plan to address the Message Code 102 issue as follows:
- Zoll Patient Service Representatives use the 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. Patients sign the WEAR Checklist and the checklist is returned to Zoll to be kept on file. Zoll updated the WEAR Checklist to include these instructions: “Call Zoll immediately if “Call for Service – Message Code 102” appears on the LifeVest screen. A replacement device will be provided within 24 hours.” The updated WEAR Checklist has been provided with each new LifeVest system shipment since March 21, 2018 as Zoll’s form of patient communication for the recall.
- Zoll is planning to implement a software design change for the LifeVest 4000 with a new, more prominent and persistent message scheme for Code 102. The proposed software change needs to be submitted to FDA for review and approval.
The FDA believes that the updated WEAR Checklist for patients with instructions about how to respond to 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 has stated it will work expeditiously to review any changes from Zoll that may affect patient safety and will continue to work with Zoll to identify a permanent solution to the Message Code 102 issue.
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