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); Shock from Patient Lead(s) (3162)

Event Date 05/28/2022

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 five inappropriate shocks.  the device was started up at 15:04:27 on (b)(6) 2022.At 15:51:47, an arrhythmia was detected.Ecg shows sinus bradycardia/rhythm from 30-70 bpm with cpr/motion artifact t.At 15:52:22, the patient received the first inappropriate treatment.Rhythm at the time of treatment was sinus rhythm @ 60 bpm with pvcs and pauses.Post shock rhythm was sinus bradycardia @ 50 bpm with pvcs and pauses.At 15:52:59, the patient received the second inappropriate treatment.Rhythm at the time of treatment was sinus bradycardia @ 40 bpm with pauses.Post shock rhythm was sinus bradycardia @ 40 bpm with pauses.At 15:53:27, the patient received the third inappropriate treatment.Rhythm at the time of treatment was sinus bradycardia @ 40 bpm with pauses.Post shock rhythm was sinus bradycardia @ 50 bpm with pauses.At 15:53:54, the patient received the fourth inappropriate treatment.Rhythm at the time of treatment was sinus bradycardia @ 50 bpm with pauses.Post shock rhythm was sinus bradycardia @ 50 bpm with pauses.At 15:54:22, the patient received the fifth inappropriate treatment.Rhythm at the time of treatment was sinus bradycardia @ 50 bpm with pauses.Post shock rhythm was sinus bradycardia @ 40 bpm with pauses.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The electrode belt was disconnected at 15:55:15 on (b)(6) 2022.The patient passed away 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: 15026447
• MDR Text Key: 295958496
• Report Number: 3008642652-2022-20981
• 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: 07/14/2022

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: 07/11/2022
• Initial Date FDA Received: 07/15/2022
• 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