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FDA alerts health care providers of treatment delivery failure in wearable defibrillators
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The FDA announced that health care providers should be aware of potential treatment delivery failure in a wearable defibrillator, which may lead to harm or death in adults with arrhythmias and children at risk for sudden cardiac arrest.
The device (LifeVest 4000, Zoll) may fail if it is not replaced after a message is displayed: “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” Failure to replace the device may result in the patient not receiving the appropriate therapy, but the message code “does not explicitly indicate that the device cannot be used and that the patient should call Zoll immediately,” according to an FDA MedWatch safety communication.
Patients with the wearable defibrillator may not receive the lifesaving shock from the original device because the high-energy capacitors are not charging, according to the safety communication.
One patient death has been reported to the FDA, which was caused by a device that displayed Message Code 102. As of November 14, 2017, 33,670 devices have been distributed, 24,975 of which are in the U.S. The displayed message affects about 0.1% of devices, according to the alert.
The FDA stated it will work with Zoll to monitor the devices for adverse events, identify a solution to the issue and inform the public.
Health care professionals are recommended to train patients to identify the message and call Zoll if it is displayed, according to the alert.
On March 6, 2019, the FDA released another MedWatch safety communication that users of the device should contact the manufacturer immediately after seeing Message Code 102 for a replacement device. In addition, Zoll is currently implementing a software update for the device to increase the importance and visibility of the alert so users know when devices should be replaced.
“The FDA 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,” according to the safety communication.
It is recommended that health care providers remind all patients who use the device to be aware of the alert and for them to call the company upon seeing it. The device will be replaced within 24 hours by the company, according to the safety communication. Patients should continue to use the device while waiting for the replacement regardless of the alert.
Editor’s Note: This article was updated on March 6, 2019 with new information from the FDA.