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Back in January 2018, the FDA announced a Class II device recall for the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator. According to the recall, under certain circumstances, the device would not deliver its life-saving shock, putting patients at risk of heart attacks and even death. The manufacturer advised patients to call for an immediate LifeVest replacement if the “Call for service—Message Code 102” appeared on the screen.

On July 25, 2018, the FDA issued an updated safety communication regarding the Zoll LifeVest, letting doctors and patients know of additional steps Zoll has taken to address the issue that caused the problem leading to the recall. So far, however, Zoll has not implemented a permanent solution.

Zoll LifeVest May Not Deliver Life-Saving Shock as Expected

The Zoll LifeVest 4000 is a wearable defibrillator designed for patients with abnormal heartbeats (arrhythmias) who are at risk for heart attack, yet aren’t good candidates for implantable defibrillators. The patient wears the vest, which continually monitors heart rate. If the device detects a fast, life-threatening heart rhythm, it first warns the patient, giving him or her the chance to stop the shock if desired. If the patient doesn’t respond, the device delivers a shock to restore the heart to a normal rhythm.

Zoll implemented the recall because in some cases, the device might not deliver the shock when needed. According to Zoll, if, during a self-check, the “call for service” message comes up, the vest is at risk for malfunction. Patients seeing the alert might not realize how serious the problem is, so Zoll issued the recall to warn them.

At the time of the recall, the FDA was aware of one patient death that occurred because of the LifeVest’s failure to deliver treatment after the message was displayed.

Zoll Implements New Checklist to Increase Patient Awareness

Since the January recall, Zoll has kept the FDA advised of their efforts to fix the devices’ problems. The company has implemented new processes it believes will increase patient safety, including the following:

  • Zoll patient services representatives now use the WEAR Checklist during patient fitting and training. Using this checklist helps reinforce instructions on how to use the device, change the battery, and respond to alerts. In this checklist is one particular instruction that tells patients to call Zoll immediately if the “call for service—Message 102” appears on the screen, after which a replacement device will be provided within 24 hours.
  • Zoll also plans to implement a software design change for the LifeVest that will make the “call for service” message more urgent and persistent. They need to submit the change to the FDA first for approval.

The FDA states that they believe the updated checklist 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 screen.” They noted that they would continue to work with Zoll to identify a permanent solution to the problem.

Meanwhile, patients are advised to be sure to respond immediately to any “call for service” messages on the LifeVest. Those who have been injured by a Zoll Life Vest may be eligible to file a Zoll LifeVest lawsuit to recover damages.

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