WASHINGTON — The FDA says the Zoll LifeVest 4000, an external, wearable cardioverter defibrillator, may fail to deliver appropriate therapy for potentially fatal arrhythmias if the device displays a specific warning, one that says little more than “Call ZOLL for service, Message Code 102.”[1]
The warning message “does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately,” the agency said in a safety communication issued today.
The company reports that 33,670 of the devices have been distributed as of November 2017, primarily in the United States, according to the announcement. The message code in question has been displayed by 0.1% of them.
The agency explains that failure of the LifeVest 4000 to deliver appropriate shocks may result from “a fault that prevents the device from charging its high-energy capacitors.” If the device is operating normally, the fault would call up the message “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on a display screen.
“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.”
The agency said it is aware of one death associated with the device’s failure to deliver treatment after the message appeared.
The LifeVest has been approved for adults since 2001, when it was owned by Lifecor before the company’s products were acquired by Zoll Medical about 10 years ago; it’s been approved for children since 2015.
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