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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Tachycardia (2095); Shock from Patient Lead(s) (3162)

Event Date 12/05/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor has been completed.Upon investigation the monitor was not properly producing a driven ground signal.The cause for the failure was isolated to an open r781 driven ground resistor on the computer/analog board.An open r781 is consistent with a patient receiving external defibrillations while wearing the lifevest.Electrode belt was returned to the distributor for evaluation.All gels were deployed.During the incoming functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes.The pulse delivery circuitry test verified proper delivery of full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition 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 in the hospital at the time of passing.Review of the patient's download data revealed that prior to passing, the patient received two treatments from the lifevest, one appropriate and one inappropriate, followed by 6 non-lifevest defibrillations.At 22:21:05, the patient received the first treatment from the lifevest.The treatment was appropriate and was delivered while the patient's rhythm was vt at 220 bpm.The post-shock rhythm was sinus bradycardia at 40 bpm with hb and nsvt.At 22:25:41, the patient received the second treatment from the lifevest.The treatment was inappropriate and was delivered while the patient's rhythm was obscured by cpr and motion artifact.The post-shock rhythm was vt at 250 bpm with motion artifact.At 22:26:01, the first non-lifevest defibrillation was delivered.The patient's rhythm at the time of the treatment was vt at 260 bpm.The post-shock rhythm was obscured by cpr and motion artifact.The patient's rhythm then degraded to vf with cpr/motion artifact/electrode lead fall off.At 22:28:07, the patient received the second non-lifevest defibrillation.The patient's rhythm at time of treatment vf with cpr/motion artifact/electrode lead fall off.The post shock rhythm cpr/electrode lead fall off.The rhythm then transitioned to bradycardia at 50 bpm with cpr/electrode lead fall off.The rhythm then degraded further to vf with cpr/electrode lead fall off.At 22:31:02, the patient received the third non-lifevest defibrillation.The patient's rhythm at time of treatment vf with cpr/motion artifact/electrode lead fall off.The post shock rhythm was obscured by electrode lead fall off.The rhythm then degraded to vf with cpr/electrode lead fall off.At 22:23:15, the patient received the fourth non-lifevest defibrillation.The patient's rhythm at time of treatment was vf with cpr/motion artifact/electrode lead fall off.The patient's post shock rhythm was cpr/electrode lead fall off.The patient's rhythm degraded to vf with cpr/motion artifact/electrode lead fall off.At 22:35:42, the patient received the fifth non-lifevest defibrillation the patient's rhythm at time of treatment was vf with varying amplitudes, motion artifact, and electrode lead fall off.The patient's post shock rhythm was obscured by cpr/electrode lead fall off.The rhythm then degraded again to vf with motion artifact, varying amplitudes, and electrode lead fall off.At 22:37:43, the patient received the sixth non-lifevest defibrillation.The patient's rhythm at time of treatment was vf with motion artifact, varying amplitudes, and electrode lead fall off.The post shock rhythm was obscured by cpr/electrode lead fall off.The patient was last seen in an idioventricular rhythm from 20-40 bpm with cpr/motion artifact and electrode lead fall off until the device shutdown at 22:42:02 on (b)(6) 2021.

• 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: 13260427
• MDR Text Key: 283848857
• Report Number: 3008642652-2022-00470
• 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: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2018
• 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): Other; Death