Urgent: Medical Device Correction

January 8, 2019

Re: Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator

Dear Health Care Provider,

The FDA approved a new software version for the ZOLL LifeVest 4000 that provides enhanced prominence and persistence of patient alerts when a “Call for service – Message Code 102” exists, instructing patients to call ZOLL immediately at 1-800-543-3267 for a replacement LifeVest. A replacement device will be provided as soon as possible, and within 24 hours at worst.

The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and a communication to Health Care Providers issued by ZOLL on January 18, 2018.

The “Call for service -- Message Code 102” has existed as a service code since the LifeVest 4000 was approved by the FDA in 2009. The unfortunate single death associated with this issue, as referenced in the FDA communication, occurred when a patient did not call ZOLL after receiving prompts for 10 consecutive days by the “Call for Service – Message Code 102” displayed on the device. In response to this rare, but potentially life-threatening situation, ZOLL modified the instructions for patients if a “Call for service -- Message Code 102” is displayed on the LifeVest device. All LifeVest patients have received that revised training since September 2017.

It is rare for a “Call for service -- Message Code 102” to be associated with a device issue that would prevent the device from being able to deliver a treatment shock. Additionally, this code can be displayed for reasons that do not impact the device’s ability to deliver a treatment shock. The rate of occurrence of a “Call for service -- Message Code 102” event is 1 in 7,000,000 patient-days of use (95% CI: 6,000,000-8,000,000).

As of tomorrow, all new patients will receive a LifeVest with this new software revision. In addition, over the next 3.5 months, ZOLL will contact all current patients and exchange their monitor for one with this new software. Patients should continue to use the LifeVest as prescribed by their physician during the software rollout and no physician action is required.

Patient safety and product quality are our primary focus at ZOLL. If you have any questions or concerns, please feel free to contact your ZOLL LifeVest representative or ZOLL Technical Services at 1-800-543-3267.

Sincerely,
Jason T. Whiting
President
ZOLL LifeVest

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