In January and July 2018, the agency and the company advised patients to contact Zoll immediately for a replacement if their device displays the message: “Call for Service—Message Code 102.” The alert indicates that the vest may have an electrical issue that causes it to fail to deliver an electrical shock to restore the patient to a normal heart rhythm.
In January 2019, FDA approved Zoll’s new software update with a more prominent and persistent patient alert for “Call for service – Message Code 102” that instructs patients to call Zoll immediately for a replacement LifeVest. The company also issued a letter to health care providers regarding the software update.
FDA said today that it learned of two patient deaths due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. The second death was reported to the agency after Zoll issued its letter on January 8, 2019. However, both deaths occurred with devices that were in use prior to the new software update, which the agency said Zoll is in the process of implementing.
The LifeVest 4000 is the only wearable cardioverter defibrillator currently available in the United States and is used by adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.
FDA said it believes that the new, more prominent and persistent patient alert for “Message Code 102” will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen.