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); Tachycardia (2095); Ventricular Fibrillation (2130); Asystole (4442)

Event Date 10/29/2021

Event Type  Death  

Manufacturer Narrative

The monitor and electrode belt were returned and evaluated at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.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.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021.It was reported that the patient was at home and experienced a treatment event from the lifevest prior to passing.The patient's spouse called ems and the patient was taken to the hospital where they passed away.Review of the patient's download data revealed that prior to passing, the patient received 8 appropriate treatment from the lifevest.From 07:55:24 to 08:02:13, the patient's rhythm was sinus tachycardia at 100-120 bpm with bigeminy, pvcs and nsvt.The rhythm then degraded to vf with varying amplitude.The varying amplitudes of the vf prevented the lifevest from treating the patient during this time.At 08:03:58, the patient received the first treatment from the lifevest.The patient's rhythm at the time of the treatment was vf with motion artifact, and the post-shock rhythm was vt at 170 bpm.At 08:04:29, the patient received the second treatment from the lifevest.The patient's rhythm at the time of the treatment was vf and the post-shock rhythm was sinus bradycardia at 30 bpm with motion artifact.At 09:00:13, the patient received the third treatment from the lifevest.The patient's rhythm at the time of the treatment was vf, and the post-shock rhythm was sinus bradycardia at 50 bpm transitioning to sinus tachycardia at 140 bpm with pvcs and nsvt.At 09:47:14, the patient's rhythm was sinus tachycardia at 120 bpm with pvcs and nsvt degrading to vf.The response buttons were pressed from 09:47:28 to 09:47:31, preventing the lifevest from delivering a treatment.It is unknown who was pressing the response buttons at this time.At 09:48:16, the patient received the fourth treatment from the lifevest.The patient's rhythm at the time of the treatment was vf, and the post-shock rhythm was sinus rhythm at 70 bpm with nsvt and pvcs.At 09:48:50, the patient received the fifth treatment from the lifevest.The patient's rhythm at the time of the treatment was vt at 250 bpm, and the post-shock rhythm was asystole for two seconds with one sinus beat transitioning to vt at 200 bpm degrading to vf.At 09:49:22, the patient received the sixth treatment from the lifevest.The patient's rhythm at the time of the treatment was vf, and the post-shock rhythm was vt at 250 bpm.At 09:49:53, the patient received the seventh treatment from the lifevest.The patient's rhythm at the time of the treatment was vt at 290 bpm, and the post-shock rhythm was sinus bradycardia at 35 bpm degrading to vf.At 09:50:15, the patient received the eighth treatment from the lifevest.The patient's rhythm at the time of the treatment was vf, and the post-shock rhythm was asystole for 2 seconds transitioning to vf with varying amplitudes.The lifevest was shutdown at 09:52:27 while the patient remained in vf with varying amplitudes.The varying amplitudes prevented the lifevest from delivering a treatment during this time.There is no indication that a device malfunction caused or contributed to the patient's passing.The equipment was returned and was found to be fully functional.

• 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: 12920503
• MDR Text Key: 281646158
• Report Number: 3008642652-2021-10624
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 11/04/2021
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• 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