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); Asystole (4442)

Event Date 08/03/2021

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 a therapy electrode recognition test.The cause for the failure was isolated to an open pulse wire in the cable connecting ecg "a" and ecg "b".The root cause for the open wire was excessive force.Device manufacture date: monitor 03/21/2012, belt 06/12/2015.

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.Per clinical review of the continuous ecg recording, the device was started up at 14:26:05 on (b)(6) 2021.The patient was in sinus rhythm at 80 bpm with pvc's and motion artifact at 23:47:30.The patient's rhythm degraded to vt at 150 bpm with varying amplitudes at 23:49:11.The patient's rhythm then degraded to asystole.The lifevest properly detected the vt arrhythmia, but varying amplitudes and the rhythm degrading to asystole prevented the lifevest from delivering a treatment.The patient's rhythm transitioned to an idioventricular rhythm at 80 bpm at 23:53:06.The patient's rhythm then slowed to sinus bradycardia at 20 bpm with nsvt before degrading to asystole at 23:53:16.The patient's rhythm transitioned to an idioventricular rhythm at 90 bpm at 23:55:56.The patient's rhythm then transitioned to sinus bradycardia at 20 bpm with cpr/motion artifact.The patient received a non-lifevest defibrillation at 00:05:45 on (b)(6) 2021.The patient's rhythm at the time of the treatment was an idioventricular rhythm at 50 bpm.The patient's post-shock rhythm was an idioventricular rhythm at 50 bpm.The patient's rhythm then transitioned to an idioventricular rhythm at 90 bpm before degrading to asystole with intermittent cardiac activity and electrode lead fall off at approximately 00:16:19.The patient was in asystole with intermittent cardiac activity and electrode lead fall off at the time of the electrode belt disconnection at 00:37:00.It was not reported who disconnected the electrode belt.The electrode belt was reconnected between 00:37:10 and 00:42:55.Electrode lead fall off obscured the patient's rhythm until the electrode belt was disconnected.

• 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: 12515313
• MDR Text Key: 272850175
• Report Number: 3008642652-2021-07595
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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: 08/16/2021
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2012
• 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): Death