Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problems
Signal Artifact/Noise (1036); Structural Problem (2506)
|
Patient Problem
Arrhythmia (1721)
|
Event Date 02/24/2024 |
Event Type
malfunction
|
Event Description
|
A us distributor contacted zoll to report that a patient passed away on (b)(6) 2024 while reportedly wearing the lifevest.The device was started up at 10:28:14 on (b)(6) 2024.The patient received five non-lifevest defibrillation from 19:08:13 to 19:16:45 on (b)(6) 2024.At 19:07:55 on (b)(6) 2024, an arrhythmia was detected.Ecg shows vf with cpr/electrode lead fall off.The device properly detected vf.Cpr/electrode lead fall off prevented the lifevest from treating the patient.The electrode belt was disconnected at 20:10:45 on (b)(6) 2024.
|
|
Manufacturer Narrative
|
Device evaluation of the monitor has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.
|
|
Manufacturer Narrative
|
Device evaluation of electrode belt has been completed.The reported problem (did not pass incoming testing) has been confirmed.Upon investigation the cable connecting the distribution node (dn) to the rear therapy electrodes was severed, damaging wires in the cable.The root cause for the severed cable was excessive force.There is no indication the severed cable caused or contributed to the patient's passing as the system was able to detect vf rhythm on the date of event.Device evaluation of the monitor has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.
|
|
Event Description
|
The electrode belt was returned for investigation and did not pass incoming functional testing.A us distributor contacted zoll to report that a patient passed away on (b)(6) 2024 while reportedly wearing the lifevest.The device was started up at 10:28:14 on 2/23/2024.The patient received five non-lifevest defibrillation from 19:08:13 to 19:16:45 on (b)(6) 2024.At 19:07:55 on (b)(6) 2024, an arrhythmia was detected.Ecg shows vf with cpr/electrode lead fall off.The device properly detected vf.Cpr/electrode lead fall off prevented the lifevest from treating the patient.The electrode belt was disconnected at 20:10:45 on 2/24/2024.
|
|
Search Alerts/Recalls
|
|