Zoll LifeVest Issue May Prevent Patients from Receiving Lifesaving Shock
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.
Related Articles
-
Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring…
-
New data presented at the Technology and Heart Failure Therapeutics (THT) Conference showed that hemodynamic monitoring can slow the progression of heart failure in patients with reduced ejection fraction.
-
The findings suggest that manufacturers need to make user interface and user experience design improvements to certain wearable medical devices.
-
Hospital at Home models are expanding capacity for overcrowded hospitals and emergency departments and providing comfort to a growing range of patients. Dave Kerwar, co-founder of Inbound Health, discusses the best candidates for hospital at home care and opportunities for…
About The Author
MedTech Intelligence Staff
The MedTech Intelligence staff consists of freelance journalists and industry contributing writers with decades of experience in covering medical device issues under the categories of business, market trends, product development, quality, regulatory, and operations.
You can contact our writing staff via our Contact Page.