FDA has released information related to concerns over whether the Zoll Medical’s LifeVest 4000 device will fail to deliver treatment. According to a safety alert via MedWatch, if the LifeVest is not replaced soon after it displays “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.”, the device could fail to delivery treatment. This failure could lead to serious patient harm or even death.
“FDA is aware that in certain cases the LifeVest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors,” according to the FDA alert. Although the device issues the above message, it does not specify that the device cannot be used and that Zoll should be immediately contacted.
As of January 17, FDA was made aware of one patient death due to the device failure to deliver treatment following the Message Code 102 display appearing on a LifeVest.
The agency has recommended that healthcare providers train patients on how to identify the “call for service” message and how to respond. The full details and instructions on how providers, patients and caregivers should respond to the LifeVest “call for service” are available on FDA’s website.