At least two patients have died after their LifeVest wearable defibrillators failed to activate. The issue seems to be an electrical problem. The U.S. Food and Drug Administration began issuing warnings about the LifeVest in January 2018, and now the manufacturer Zoll Medical Corporation has issued a voluntary recall. It is also deploying a software update to address the problem.
According to both the FDA and Zoll, the defect only affects a small percentage of the vests on the market. Users should pay attention if their vests display the warning, “Call for service – Message Code 102.” This indicates that product service is required immediately because the vest might not activate during a heart attack.
Tragically, Zoll says that the first person who died after their LifeVest failed did not heed the call for service. The “Call for service – Message Code 102” warning had apparently appeared on the deceased’s vest for 10 consecutive days, but the person did not call for service. Since that time, Zoll has been providing every LifeVest patient with training to heed such warnings and call for help immediately.
Yet that training didn’t prevent a second death, which occurred after the voluntary recall but before the software update was deployed.
Why not ‘Danger: Call for Service Immediately’?
A reasonable person might ask if the message “Call for service – Message Code 102” was sufficient to warn patients of a potentially life-threatening defect in the device or its software. Even with patient training, the message might strike people as insufficiently urgent or specific.
Other problems with the LifeVest
According to reports, the two deaths from LifeVests that failed to activate during heart attacks are not the only issues being reported. However, the company is reportedly facing at least two wrongful death lawsuits in connection with failing vests.
The FDA also received a number of complaints about LIfeVests that activated when there was no heart attack. In one case, an 11-year-old girl allegedly received multiple false alarms and has suffered burns as a result.
Finally, questions have been raised about whether the LifeVest is actually effective at preventing deaths from heart attacks. A 2018 study found that the use of defibrillating vests by patients who had previously suffered a heart attack did reduce their overall death rate, but strangely it did not reduce the number of deaths from heart attacks.
If you have been injured or a loved one has lost their life while using a Zoll LifeVest, you may have legal recourse. Contact an attorney with experience in medical device liability cases.