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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 12/08/2021

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021 while wearing the lifevest.It was reported that the patient was in the hospital with staff present prior to passing.Review of the patient's download data revealed that prior to passing, the patient received 3 inappropriate treatment from the lifevest.At 12:23:40, the lifevest detected an arrhythmia.The patient's ecg at this time shows asystole with intermittent cardiac activity and cpr/motion artifact.At 12:24:16, the patient received the first treatment from the lifevest while the rhythm was obscured by cpr and motion artifact.The post-shock rhythm was also obscured by cpr and motion artifact.At 12:24:48, the patient received the second treatment from the lifevest while their rhythm was obscured by cpr and motion artifact.The post-shock rhythm was bradycardia at 20 bpm with pvc's and cpr/motion artifact.At 12:43:47, the patient received the third treatment form the lifevest while their rhythm was obscured by cpr and motion artifact.The post shock rhythm was asystole with tactile artifact and electrode lead falloff.At 12:46:51, the electrode belt was disconnected.It was reported that the lifevest was removed by hospital staff so that resuscitation attempts could be made.Oversensing of low amplitude cardiac signal, cpr/motion, and tactile artifact contributed to the false detections.The response buttons were not pressed during the event.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.

Manufacturer Narrative

Device evaluation of the monitor and electrode belt 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.

• 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: 13260404
• MDR Text Key: 283927910
• Report Number: 3008642652-2022-00494
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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: 12/14/2021
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2012
• 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): Other; Death