An Error Message Worth Taking to Heart

In today's digital world we encounter alert messages on everything from our computers and mobile devices to our washing machines. It's not unusual to become desensitized to these messages and let them go ignored for too long. But a recent FDA safety communication serves as a reminder that some alerts warrant immediate attention, particularly when they involve a medical device that is supposed to keep you alive. The agency warned patients and caregivers that the Zoll LifeVest 4000, a wearable defibrillator used to treat life-threatening arrhythmias in adults and children at risk for sudden cardiac arrest, may fail to deliver treatment when needed if the device is not replaced soon after displaying a message instructing the user to call Zoll for service. Although the alert does inform the user that the device has a problem that may require service, FDA said the message does not explicitly indicate that the device cannot be used and that the patient should call Zoll immediately. At least one patient has died due to the LifeVest's failure to deliver treatment as expected after the message code was displayed on the device. According to Zoll, as of Nov. 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the United States. About 0.1% of the total devices distributed have displayed this particular alert, which is labeled Message Code 102. The company said the alert can only be resolved by immediate replacement of the device. FDA recommends ...
Source: MDDI - Category: Medical Devices Authors: Tags: Electronics Source Type: news