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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Over-Sensing (1438)

Patient Problem Arrhythmia (1721)

Event Date 01/23/2024

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 not been recovered.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) 2024 while reportedly wearing the lifevest.The patient received four appropriate treatments and five inappropriate treatments.The device was started up at 12:49:58 on (b)(6) 2024.At 04:56:55 on (b)(6) 2024, an arrhythmia was detected.Ecg shows sinus tachycardia @ 100 bpm degrading to vf.At 04:57:36, the patient received the first appropriate treatment.The rhythm at the time of treatment was vf.Post shock rhythm was sinus rhythm @ 85 bpm transitioning to vt @ 250 bpm.At 04:57:57, the patient received the second appropriate treatment.The rhythm at the time of treatment was vt @ 240 bpm.Post shock rhythm was sinus bradycardia @ 50 bpm with nsvt degrading to asystole with unconducted p waves.At 04:58:29, the patient received the first inappropriate treatment.Oversensing of cardiac activity and nsvt contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with unconducted p waves.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with unconducted p waves/intermittent cardiac signal.At 04:59:0,1 the patient received the third appropriate treatment.The rhythm at the time of treatment was vt @ 180 bpm.Post shock rhythm was sinus tachycardia @ 130 bpm with pvcs/nsvt and hb.At 05:00:15, the patient received the second inappropriate treatment.Oversensing of cardiac activity and nsvt contributed to the false detection.The rhythm at the time of treatment was sinus bradycardia @ 50 bpm with pvcs and hb.Post shock rhythm was sinus rhythm @ 60 bpm with pvcs and hb.At 05:00:54, the patient received the third inappropriate treatment.Oversensing of cardiac activity and nsvt contributed to the false detection.The rhythm at the time of treatment was sinus tachycardia @ 140 bpm with pvcs/nsvt and hb.Post shock rhythm was sinus rhythm @ 70 bpm with pvcs and hb.At 05:01:26, the patient received the fourth inappropriate treatment.Oversensing of cardiac activity and nsvt contributed to the false detection.The rhythm at the time of treatment was sinus tachycardia @ 140 bpm with pvcs/nsvt and hb.Post shock rhythm was sinus rhythm @ 80 bpm with pvcs/nsvt and hb.At 05:01:48, the patient received the fourth appropriate treatment.The rhythm at the time of treatment was vt @ 230 bpm.Post shock rhythm was vt @ 220 bpm degrading to asystole with unconducted p waves for 6 seconds.At 05:02:17, the patient received the fifth inappropriate treatment.Oversensing of cardiac activity and nsvt contributed to the false detection.The rhythm at the time of treatment was sinus tachycardia @ 110 bpm with pvcs/nsvt and hb.Post shock rhythm was sinus rhythm @ 80 bpm with pvcs/nsvt and hb transitioning back to vt @ 260 bpm degrading to vf.The electrode belt was disconnected at 05:19:43 on (b)(6) 2024.

• 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: 18771117
• MDR Text Key: 336138114
• Report Number: 3008642652-2024-02099
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• 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: 02/23/2024

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: 02/09/2024
• Initial Date FDA Received: 02/23/2024
• 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