The Zoll LifeVest 4000 is a wearable defibrillator that is used to treat life-threatening abnormal heartbeats (arrhythmias).
The LifeVest continuously monitors the patient’s heart. If it detects an abnormally fast heartbeat, it delivers a shock to restore heart rhythm.
Unfortunately, about 0.1% of the LifeVest 4000 devices have displayed Message Code 102, an error that prevents the device from charging its high-energy capacitors.
The error can only be fixed by immediately replacing the device.
Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death because the defibrillator may not work.
The FDA is aware of 1 patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed.
Zoll reports that as of November 14, 2017, a total of 33,670 devices were distributed worldwide, with 24,975 in the U.S. The error can only be fixed by immediate replacement of the device.
The FDA is asking healthcare professionals to train patients with the Zoll LifeVest 4000 on how to identify the “Call for service, Message Code 102” alert.
Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
Source: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure