The device failure was traced to a fault that prevents the LifeVest from charging its high-energy capacitors, according to the alert.
A patient who died when a ZOLL LifeVest failed to work has led the manufacturer Zoll Medical and the FDA to issue a safety alert for physicians and patients using the wearable heart monitor and external defibrillator.
The device failure was traced to a fault that prevents the LifeVest from charging its high-energy capacitors, according to the alert. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. But the problem is that 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.
