The FDA issued a safety alert Jan. 17 for the Zoll LifeVest 4000, saying the external, wearable cardioverter defibrillator may fail to treat potentially fatal arrhythmias if it displays a specific error message which, by itself, doesn’t signal urgency.
According to the FDA, the device may fail to deliver appropriate shock treatment soon after displaying, “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” The message is prompted by a fault that prevents the device from charging its high-energy capacitors.
“The ‘Message Code 102’ alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately,” the FDA’s safety alert said.
The agency is aware of one patient death due to the LifeVest’s failure to deliver treatment after Message Code 102 was displayed. It recommended healthcare providers tell patients how to identify the alert and to call Zoll immediately if they see it.
“Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing,” the FDA said.