Defibrillator Recall: Wearable Defibrillators Recalled after Injuries and Deaths Reported

defibrillator recall

Zoll Medical Corporation issued a recall of their wearable defibrillator LifeVest 4000 after the U.S. Food & Drug Administration (FDA) received reports of two deaths and an undisclosed number of miscellaneous injuries.  This defibrillator recall is intended to prevent a potentially deadly malfunction.

What is the LifeVest 4000?

The Zoll LifeVest 4000 is a medical device worn like a vest for the purposes of as-needed defibrillation, otherwise known as a wearable defibrillator.  It is used to treat abnormal heartbeats, or arrhythmias, in both adults and children who require treatment for the risk of sudden cardiac arrest.

Arrhythmia patients who use wearable defibrillators are usually not good candidates for surgically implanted internal defibrillators.  Quite frequently, pediatric patients with arrhythmias will use wearable defibrillators because their irregular heartbeat is temporary, and they only require treatment to bridge the period of time until their heart condition corrects itself.

Wearable defibrillators monitor the user’s heart rate continuously to administer an electric shock if a dangerous heart rhythm is detected.

Do Wearable Defibrillators Pose Danger to All Users?

The Zoll LifeVest is a danger to users when it malfunctions, and it is the only wearable defibrillator on the market.  By and large, these devices are life-saving measures for patients with serious heart conditions.  The good they do outweighs, in large measure, the potential harm done.

That said, Zoll Medical Corporation’s LifeVest 4000 has caused enough harm to prompt FDA and media attention, as well as a variety of lawsuits.  Are wearable defibrillators dangerous for all users? Probably not.  However, there is no way to tell which devices will malfunction, or when.

Product Details of this Malfunctioning Defibrillator

This defibrillator recall is a concern for all consumers who have wearable defibrillators themselves, or who have loved ones who depend on the device.  Consumers who should take immediate action because of this defibrillator recall are:

  • Patients with a Zoll LifeVest 4000 wearable defibrillator
  • Healthcare professionals and other caregivers of patients using a Zoll LifeVest 4000 wearable defibrillator
  • Physicians including cardiologists, cardiac surgeons, electrophysiologists, and primary care providers who treat patients with heart rhythm conditions with a Zoll LifeVest 4000 wearable defibrillator

Deaths That Prompted This Defibrillator Recall

The Zoll LifeVest has been on the market with FDA approval since 2009.  In that time, two deaths have occurred among patients using the device.  Both deaths were linked to identical malfunctions with the defibrillator.  When the vest malfunctions, it will display an error code reading, “Call for Service—Message Code 102”.  Consumers have discovered in the most tragic way possible that this code means the device must be replaced immediately.  Both deaths occurred when the vests displaying this message failed to provide life-saving defibrillation when needed by the patient.

Though home-users of the vest receive training before use of the Zoll LifeVest, the company says users were not adequately trained about the immediate and potentially deadly urgency of the “Call for Service—Message Code 102.” The first death occurred when a patient’s device displayed this message for ten days and then failed to function when defibrillation was needed.

The manufacturer began revised training for consumers regarding the, “Call for Service—Message Code 102” message, and also issued a software update for the devices designed to make the error message more noticeable.

Adverse Side Effects of Malfunctioning Medical Devices

In addition to the deaths reported, multiple users have reported a variety of injuries.  Consumers have reported burns and rashes to the FDA, as well as reported instances when the device issued false alarms or activated prematurely.  One 11-year-old girl’s device issued false alarms and burned her while she used it.

Based on FDA reports, the LifeVest 4000 may malfunction in various ways, including:

  • An error code, “Call for Service—Message Code 102,” displays.  This error code requires immediate replacement of the device without indicating the code means a potentially deadly malfunction.
  • The device sometimes misreads heart rates and misfires, giving an arrhythmic patient an unnecessary and dangerous electrical shock.
  • Unnecessary electrical shocks can cause burns and rashes.

When medical devices malfunction, consumers pay the price.  Especially in the case of a wearable defibrillator, the consequences are scary.  Patients who need a wearable defibrillator have serious heart conditions.  Their state of health is already fragile.  When devices they depend on malfunction, any misfire or additional pain puts their life at risk.

Adverse side effects from malfunctioning devices can include:

  • Pain, burns, or injuries
  • Additional hospital stays
  • Prolonged hospital stays
  • Increased medical bills
  • Additional surgery

Malfunctioning medical devices are especially dangerous for pediatric patients, like the 11-year-old girl whose LifeVest defibrillator malfunctioned.  The FDA has only recently approved wearable defibrillators for children, so the extent of the harm these devices can cause is not fully known.

However, a recent study of the use of wearable defibrillators in pediatric patients revealed that malfunction and injury are disturbingly common.  According to a study published in Cardiac Rhythm News, the device misread heart signals and delivered an unnecessary shock in 25 percent of the patients whose device discharged defibrillation intended to be therapeutic.

What to do if you use a Zoll LifeVest 4000

Zoll addressed this deadly situation in a statement indicating deaths occurred because the error code “Call for Service—Message Code 102” was somewhat nonchalant and didn’t adequately express the danger is posed to users.

Users should contact Zoll immediately if an error code appears on their LifeVest device.  Zoll will repair or replace the device as needed.  Both the FDA and the manufacturer warn that waiting to replace the device could have deadly consequences.  The first death attributed to this defibrillator recall occurred when the user’s device had been displaying the error message for only 10 days.

Their statement did not address the other FDA complaints of burns and other injury from misfiring devices.

Contact Zoll Technical Services at 1-800-543-3267 for more information.  You can also file a complaint with the FDA for any malfunction through their MedWatch reporting program.

If you or a loved one have experienced malfunction of this device, it’s also a good idea to speak to a defibrillator recall attorney about your injuries and experience.  You may have a claim for compensation.

If you are a healthcare provider, remind patients who use these wearable defibrillators of the dangers of an error code.  This defibrillator recall is affecting arrhythmia patients nationwide, and healthcare providers must be diligent in warning their patients.

What Are my Rights if My Defibrillator Malfunctions?

Consumers have a right to expect that a medical device will function in the manner intended.  They also have a right to have accurate information and training on the maintenance and care of a device that provides them with a life-saving service.

This defibrillator recall indicates that Zoll failed consumers with respect to both of these rights.  The device misreads heart rates and misfires.  Additionally, the company failed to train home-users appropriately about potentially deadly error codes.  As a result, two people have died, and many others including children have been unnecessarily shocked and burned by this device.  If this has happened to you, call a medical device attorney now.

What Will it Cost to Talk to a Medical Device Attorney?

Consulting with a lawyer about your experience with this defibrillator recall is free.  When medical devices fail, American consumers/patients pay the price.  You have a right to use safe medical products.  You have a right to trust your medical device will function properly.

If you were harmed by this or any other malfunctioning medical device, you have a right to hold the at-fault party responsible for your pain, medical bills, and potentially more.  Don’t wait another day if you have suffered because of this defibrillator recall.  Contact a medical device attorney now.