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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130)

Event Date 09/17/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of the monitor sn (b)(4) has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, 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 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.Electrode belt sn (b)(4) has not yet been recovered from the field.Device evaluation included review of downloaded software flag files on the day of the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the patient's passing.

Event Description

A us distributor contacted zoll to report that a french patient passed away on (b)(6) 2021 while wearing the lifevest.The patient was in the hospital at the time of passing.Review of the patient's download data reveals that prior to passing, the patient received 6 appropriate and 2 inappropriate treatments from the lifevest.At 12:17:16, the patient received the first treatment from the lifevest while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was sinus rhythm at 70 bpm with pvcs and nsvt degrading to vf.At 12:17:48, the patient received the second treatment from the lifevest while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was sinus rhythm at 80 bpm with pvcs degrading to vf.At 12:18:59, the patient received the third treatment from the lifevest while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was vt at 250 bpm transitioning to sinus bradycardia at 50 bpm.At 13:05:21, the patient received the fourth treatment from the lifevest while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was sinus rhythm at 60 bpm with nsvt.At 13:05:43, the patient received the fifth treatment from the lifevest while their rhythm was nsvt.The treatment was inappropriate.The post-shock rhythm was sinus rhythm at 90 bpm with pvcs and nsvt.At 13:06:13, the patient received the sixth treatment from the lifevest while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was sinus rhythm at 60 bpm with pvcs.The rhythm then degrades to vt at 270 bpm.At 13:07:23, the patient received the seventh treatment from the lifevest while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was sinus bradycardia at 50 bpm with a pause and cpr/motion artifact.At 15:02:37, the patient received the eighth treatment from the lifevest while their rhythm was nsvt.The treatment was inappropriate.The post-shock rhythm was sinus tachycardia at 130 bpm with motion artifact/lead falloff.Nsvt contributed to the false detections.The response buttons were not pressed during the event.There is no indication that a device malfunction caused of contributed to the patient's passing.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: mary ward ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12677608
• MDR Text Key: 277837998
• Report Number: 3008642652-2021-09345
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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: 10/21/2021

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: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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; Other