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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Device Fell (4014)

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

Event Date 07/27/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of electrode belt (b)(4) has been completed.The electrode belt ecg acquisition and pulse delivery circuitry was tested and found to be fully functional.There is no indication of a product malfunction.Device evaluation of monitor (b)(4) 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.Device manufacture date.Monitor 01/18/2012.Belt 04/29/2015.

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.It was reported that hospital staff performed resuscitation efforts.Review of the patient's download data indicates the patient received two appropriate treatments on (b)(6) 2021, the day prior to the patient's passing and seven external defibrillations on the date of passing.The patient was in sinus rhythm at 80 bpm with pvc's and nsvt at 20:57:33 on (b)(6) 2021.The patient's rhythm transitioned to vt at 260 bpm at 20:57:46.The patient received the first appropriate treatment at 20:58:21.The patient's rhythm at the time of treatment was vt at 270 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient was in sinus tachycardia at 100 bpm at 21:31:06.The patient's rhythm transitioned to vt at 250 bpm at 21:52:24.The patient received the second appropriate treatment at 21:52:54.The patient's rhythm at the time of treatment was vt at 240 bpm.The patient's post-shock rhythm was sinus rhythm at 60 bpm.The device was shutdown at 01:08:07 on (b)(6) 2021 while the patient was in sinus rhythm at 80 bpm.The device was started up again at 03:42:50.The patient was in sinus tachycardia at 100 bpm at 10:54:13.The patient's rhythm transitioned to vt at 180 bpm.The lifevest detected the vt arrhythmia, but the patient's rhythm self-converted to sinus bradycardia with cpr/motion artifact, preventing the lifevest from delivering a treatment.The patient's rhythm then transitioned to sinus rhythm/sinus tachycardia from 80-130 bpm with nsvt.The patient's rhythm then degraded to vt at 170 bpm with motion artifact at 10:58:11.The lifevest detected the vt arrhythmia, but the patient was externally defibrillated at 10:58:58, preventing the lifevest from delivering a treatment.The patient's rhythm at the time of the external defibrillation was vt at 170 bpm.The patient's post-shock rhythm was sinus tachycardia at 100 bpm with motion artifact.The patient was in svt at 150 bpm at 11:02:24.The patient's rhythm transitioned to vt at 180 bpm at 11:02:38.The patient received a second external defibrillation at 11:02:57.The patient's rhythm at the time of treatment was vt at 180 bpm with cpr/motion artifact.The patient's post-shock rhythm was sinus tachycardia at 100 bpm with cpr/motion artifact.Cpr artifact and the patient not being in the detection sequence long enough prevented the lifevest from detecting the arrhythmia.The lifevest typically requires 60 seconds of sustained vt to deliver a treatment shock.The patient's rhythm transitioned to svt at 150 bpm before degrading to vt at 200 bpm with cpr/motion artifact at 11:05:26.The patient received a third external defibrillation at 11:05:42.The patient's rhythm at the time of treatment was vt at 200 bpm.The patient's post-shock rhythm was vt at 200 bpm with cpr/motion artifact.The patient's rhythm degraded to vf with cpr/motion artifact at 11:06:07.The patient received a fourth external defibrillation at 11:07:30.The patient's rhythm at the time of treatment was vf with cpr/motion artifact.The patient's post-shock rhythm was obscured by cpr/motion artifact.Cpr/motion artifact prevented the lifevest from detecting the vf arrhythmia.The patient remained in vf with cpr/motion artifact until receiving the fifth external defibrillation at 11:09:47.The patient's rhythm at the time of treatment was vf with cpr/motion artifact.The patient's post-shock rhythm was one sinus beat with cpr/motion artifact.The patient's rhythm transitioned to sinus rhythm/sinus tachycardia from 80 to 100 bpm before degrading to vt at 200 bpm with cpr/motion artifact at 11:11:40.The patient received the sixth external defibrillation at 11:11:57.The patient's rhythm at the time of treatment was vf with cpr/motion artifact.The patient's post-shock rhythm was sinus rhythm at 60 bpm with motion artifact and electrode lead fall off.The patient's rhythm transitioned to sinus tachycardia at 100 bpm with pacemaker spikes and cpr/motion artifact.The patient's rhythm then degraded to vf with cpr/motion artifact at 11:13:41.The patient received a seventh external defibrillation at 11:14:04.The patient's rhythm at the time of treatment was vf.The patient's post-shock rhythm was obscured by cpr/motion artifact and electrode lead fall off.The patient was in vf with cpr/motion artifact and varying heart rate from 11:15:56 until the device shutdown at 11:16:43.Cpr/motion artifact and varying heart rate prevented the lifevest from detecting the vf 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: 12564903
• MDR Text Key: 274519529
• Report Number: 3008642652-2021-07675
• 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: 10/01/2021

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: 08/06/2021
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2012
• 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