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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Decreased Sensitivity (2534); High Sensing Threshold (2574)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 11/05/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of the 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.The open r781 resistor is consistent with the patient receiving an external defibrillation while wearing the lifevest.The electrode belt has been returned and the evaluation is underway.The device flag data from the last download ((b)(6) 2021) does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.No deficiencies alleged.Device manufacture date: monitor 09/02/2020.Belt 03/04/2014.

Event Description

A us distributor contacted zoll to report that a patient passed away in the hospital while wearing the lifevest on (b)(6) 2021.Review of the patient's download data indicates the patient received one appropriate shock and three external defibrillations on the date of passing.The device was started up at 19:40:53 on (b)(6) 2021.The patient was in an idioventricular rhythm at 40 bpm, transitioning to svt at 150 bpm with cpr/motion artifact at 03:15:20 on (b)(6) 2021.The patient's rhythm degraded to vf with cpr/motion artifact at 03:18:14.The patient received the appropriate shock at 03:18:51.The patient's rhythm at the time of the shock was vf with cpr/motion artifact.The patient's post-shock rhythm was vt at 250 bpm, self-converting to sinus bradycardia at 45 bpm with cpr/motion artifact and electrode lead fall off.The patient was in sinus bradycardia/sinus tachycardia from 30 to 140 bpm with hb and cpr/motion artifact.The patient received the first external defibrillation at 03:30:28.The patient's rhythm at the time of the shock was sinus rhythm at 80 bpm with cpr/motion artifact and electrode lead fall off.The patient's post-shock rhythm was sinus rhythm at 90 bpm.The patient received the second external defibrillation at 03:33:43.The patient's rhythm at the time of the shock and post-shock rhythm were sinus rhythm at 80 bpm with cpr/motion artifact and electrode lead fall off.The patient's rhythm degraded to vt from 150 to 160 bpm at approximately 03:36:40.The patient's rhythm then degraded to vf with cpr/motion artifact and electrode lead fall off.The patient received the third external defibrillation at 03:37:06.The patient's rhythm at the time of the shock was vf with cpr/motion artifact.The patient's post-shock rhythm was sinus tachycardia at 120 bpm with cpr/motion artifact and electrode lead fall off.Cpr/motion artifact, electrode lead fall off, and the external defibrillation prevented the lifevest from detecting the vt/vf arrhythmia.The patient was in sinus tachycardia/sinus rhythm from 120 to 60 bpm with pvc's, cpr/motion artifact and electrode lead fall off.The patient's rhythm then degraded to vt from 120 to 150 bpm with cpr/motion artifact and electrode lead fall off at 03:52:49.The patient remained in vt until the electrode belt disconnection at 03:53:49 on (b)(6) 2021.Cpr/motion artifact, electrode lead fall off, the rate of the vt arrhythmia varying below the physician-prescribed rate threshold of 150 bpm, and the electrode belt disconnection prevented the lifevest from detecting the vt arrhythmia.

• 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: 12976305
• MDR Text Key: 282058503
• Report Number: 3008642652-2021-10774
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: 11/12/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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