UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication
Date Issued: July 25, 2018
- 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
Cardiac Electrophysiology, Cardiology, Cardiac Surgery
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 a treatment (i.e. a shock) to restore the patient to a normal heart rhythm.
The FDA is providing additional information regarding efforts by Zoll, the manufacturer, to remedy the potential hazard of the device failing to deliver a shock to a patient if needed after the LifeVest 4000 displays "Call for Service - Message Code 102." The FDA is informing users of Zoll’s patient communication strategy to help ensure the safe use of the Zoll LifeVest 4000.
Summary of Problem and Scope:
In January 2018, the FDA issued a Safety Communication alerting patients and health care providers that the LifeVest 4000 may fail to deliver a life-saving shock to a patient if the device is not replaced soon after displaying "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 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.
Recommendations for Health Care Providers:
- Reinforce initial LifeVest 4000 training and the WEAR Checklist, including instructions for patients on how to respond to the "Call for service, Message Code 102" alert.
- Message Code 102 will first present as a visual alert accompanied by an audible gong alert, and then subsequently at every time the device is powered on until the device is returned to Zoll for servicing. The alert will read "Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102" and will allow the patient to tap "OK" to return to normal operation.
- Inform patients to respond to the "Call for service, Message Code 102" alert on the LifeVest 4000 screen by contacting Zoll immediately. Message Code 102 means that the LifeVest 4000 has a potentially severe 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. Zoll’s Customer Service can be reached 24 hours a day and 7 days a week at: 1-800-543-3267.
- If Message Code 102 does NOT appear on the device screen, the patient should read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).
Recommendations for Patients and Caregivers:
- Contact Zoll immediately if the following message appears on your LifeVest 4000 Screen: "Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102."
- Message Code 102 will first present as a visual alert accompanied by an audible gong alert, and then subsequently every time the device is powered on until the device is returned to Zoll for servicing. The Message Code 102 alert will also allow you to tap "OK" to return to normal operation.
- The "Call for service, Message Code 102" alert means that the LifeVest 4000 has a potentially severe service problem and the device may not deliver a life-saving shock if needed. Zoll will replace your device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
- o If the "Call for service, Message Code 102" alert is NOT displayed on your device screen you should continue to read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).
The FDA continues to work with Zoll to monitor and correct the Message Code 102 issue. The FDA will provide additional updates as new information becomes available.
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 FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
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.