Zoll Life Vest
A patient who died when a Zoll LifeVest failed to work has led the manufacturer Zoll Medical and the FDA to issue a safety alert for physicians and patients using the wearable heart monitor and external defibrillator.
The device failure was traced to a fault that prevents the LifeVest from charging its high-energy capacitors, according to the alert. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. But the problem is that the “Message Code 102” alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.
As of November 14 last year, 33,670 devices had been distributed, with 24,975 devices distributed in the U.S, according to Zoll Medical, which is part of the Asahi Kasei Group. About 0.1 percent of the total devices distributed have displayed Message Code 102, which should only be remedied by immediate replacement of the device, the alert said.
“To date, FDA is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed,” according to the alert.
The alert advised patients and caregivers if they receive the message, “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” on their LifeVest 4000 screen to contact Zoll immediately. It also advised physicians to train patients prescribed the device how to identify the “Call for service, Message Code 102” alert.
The FDA has been working with Zoll Medical to monitor LifeVest 4000 devices for adverse events tied to Message Code 102 or a failure to deliver treatment. But the company and regulator are also working on a permanent fix to the fault.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Zoll did not respond to requests for comment.
Earlier this month, Zoll received premarket approval from the FDA to continue to market and distribute its defibrillators in the U.S. Last year, the company inked a strategic collaboration with Canadian manufacturer Myant, which is developing ways to integrate technology and soft electronics into textiles, for a multi-year agreement to jointly develop technologies that will be used in future versions of Zoll’s products.
