MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 07/07/2022

Event Type  Death  

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.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2022 while reportedly wearing the lifevest.The patient received three appropriate treatments, two of which converted the arrhythmias to a slower rhythm and one which resulted in a post shock asystole, and two inappropriate treatments.  the device was started up at 23:47:19 on (b)(6) 2022.At 01:52:23 on (b)(6) 2022, an arrhythmia was detected.Ecg asystole with cpr/motion artifact.The rhythm then degrades to vt @ 160 bpm with cpr/motion artifact.At 01:53:32, the patient received the first appropriate treatment.The rhythm at the time of treatment was vt @ 140 bpm with cpr/motion artifact.The post shock rhythm was idioventricular rhythm @ 50 bpm with cpr/motion artifact.At 01:54:01, the patient received the second appropriate treatment.The rhythm at the time of treatment was vt @ 160 bpm with cpr/motion artifact.The post shock rhythm was sinus bradycardia @ 50 bpm with motion artifact degrading to asystole.At 01:58:45, an arrhythmia was detected.Ecg shows cpr/motion artifact.At 02:00:03, the patient received the first inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non-life sustaining rhythm prior to the shock.The rhythm at the time of treatment was cpr/motion artifact/asystole one second before the treatment was delivered.The post shock rhythm was idioventricular rhythm @ 35 bpm degrading to asystole.At 02:03:58, an arrhythmia was detected.Ecg shows asystole with cpr/motion artifact.At 02:04:51, the patient received the second inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non-life sustaining rhythm prior to the shock.The rhythm at the time of treatment was asystole with cpr/motion artifact.The post shock rhythm was asystole with cpr/motion artifact.At 02:08:33, an arrhythmia was detected.Ecg shows vf with cpr/motion artifact.At 02:09:05, the patient received the second appropriate treatment.The rhythm at the time of treatment was vf with cpr/motion artifact.The post shock rhythm was asystole with cpr/motion artifact.The rhythm then transitions to an idioventricular rhythm @ 10 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The electrode belt was disconnected at 03:01:00 on (b)(6) 2022.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 15236141
• MDR Text Key: 298004949
• Report Number: 3008642652-2022-22253
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 08/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death