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); Failure to Convert Rhythm (1540); Use of Device Problem (1670); Connection Problem (2900)

Patient Problems Bradycardia (1751); Tachycardia (2095)

Event Date 08/24/2022

Event Type  Death  

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 six appropriate treatments, five of which did not convert the arrhythmia to a slower rhythm.The device was started up at 13:08:28 on (b)(6) 2022.At 05:37:35 on (b)(6) 2022, an arrhythmia was detected.Ecg shows vt @ 190 bpm with motion/tactile artifact.At 05:38:53, the patient received the first appropriate treatment.The rhythm at the time of treatment was vt @ 190 bpm with motion/tactile artifact.The post shock rhythm was sinus bradycardia @ 40 bpm with motion/tactile artifact and electrode lead falloff.At 06:35:35, an arrhythmia was detected.Ecg shows vt @ 200 bpm with motion/tactile artifact and electrode lead falloff.At 06:38:03, the patient received the second appropriate treatment.The rhythm at the time of treatment was vt @ 190 bpm with motion/tactile artifact and electrode lead falloff.The post shock rhythm was vt @ 190 bpm with motion/tactile artifact and electrode lead falloff.At 06:38:33, the patient received the third appropriate treatment.The rhythm at the time of treatment was vt @ 190 bpm with motion/tactile artifact and electrode lead falloff.The post shock rhythm was vt @ 190 bpm with motion/tactile artifact and electrode lead falloff.At 06:38:59, the patient received the fourth appropriate treatment.The rhythm at the time of treatment was vt @ 180 bpm with motion/tactile artifact and electrode lead falloff.The post shock rhythm was vt @ 180 bpm with motion/tactile artifact and electrode lead falloff.At 06:39:29, the patient received the fifth appropriate treatment.The rhythm at the time of treatment was vt @ 180 bpm with motion/tactile artifact and electrode lead falloff.The post shock rhythm was vt @ 180 bpm with motion/tactile artifact and electrode lead falloff.At 06:39:56, the patient received the sixth appropriate treatment.The rhythm at the time of treatment was vt @ 170 bpm with motion/tactile artifact and electrode lead falloff.The post shock rhythm was vt @ 170 bpm with motion/tactile artifact and electrode lead falloff.The impedance was 0 during pulse deliveries 2-6.The electrodes were not properly attached to the skin.Therefore the device only produced 9-10 joule shocks for treatments 2-6 resulting in the arrhythmias not being converted to a slower rhythm.The electrode belt was disconnected at 09:12:51 on (b)(6) 2022.

Manufacturer Narrative

Device evaluation of the monitor has been completed.During the incoming functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz 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.

• 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: 15411857
• MDR Text Key: 299791414
• Report Number: 3008642652-2022-23378
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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
• Date Manufacturer Received: 09/09/2022
• 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