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); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 08/06/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) 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.Device evaluation of electrode belt sn (b)(4) has been completed.Upon investigation the electrode belt failed an ecg fall-off test.The cable connecting ecg "c" and ecg "d" was pulled from the strain relief, breaking the wires from the j704 connector on the distribution node pca.The root cause for the strained cable was excessive force.There is no indication the damaged belt caused or contributed to the patient's passing.The device was able to detect the patient's ecg rhythm throughout the event.Device manufacture date: monitor 05/16/2018.Belt 03/01/2019.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2021.Review of the patient's download data indicates the patient received one inappropriate shock in response to oversensing of low amplitude cardiac signal on the date of passing.The patient was in af with rvr and motion artifact at 18:01:29 on (b)(6) 2021.The patient's rhythm transitioned to sinus bradycardia from 30 to 10 bpm with low amplitude cardiac activity at 19:58:29.The patient was in sinus bradycardia at 20 bpm degrading to asystole at 19:58:34.The patient's rhythm transitioned to sinus bradycardia at 50 bpm with motion artifact and electrode lead fall off at 20:05:28.The patient's rhythm degraded to asystole with intermittent cardiac activity and motion artifact at 20:11:18.The patient received the inappropriate shock at 20:13:22.The patient's rhythm at the time of the shock was asystole with intermittent cardiac activity and low amplitude cardiac signal.The patient's post-shock rhythm was asystole with intermittent cardiac activity, low amplitude cardiac signal, and motion artifact.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12483538
• MDR Text Key: 271794687
• Report Number: 3008642652-2021-08091
• 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: 09/16/2021

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: 08/24/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• 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