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 Problem Bradycardia (1751)

Event Date 10/11/2021

Event Type  Death  

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 download data, indicates the patient received two appropriate treatments during vf.From 07:22:04 to 07:42:19, the patient was in sinus bradycardia/sinus tachycardia from 50-120 bpm with motion artifact and electrode lead fall off.The rhythm then degrades to vf with motion artifact and electrode lead fall off.Vf was seen from 07:41:29 to 07:42:19.Motion artifact and electrode lead fall off obscured the rhtyhm and prevented the lifevest from treating the patient.At 07:43:56, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vf with cpr/tactile/motion artifact.The patient's post-shock rhythm was sinus bradycardia at 20 bpm with bbb/cpr/tactile/motion artifact.At 07:48:38, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vf with cpr/tactile/motion artifact.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with cpr/tactile/motion artifact.The electrode belt was disconnected at 08:33:46.

Manufacturer Narrative

Device evaluation of the monitor 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.The electrode belt has not been recovered.The device flag data from the last download does not indicate any device malfunction.

• 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: steven kyle ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13709608
• MDR Text Key: 286844018
• Report Number: 3008642652-2022-02320
• 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: 03/08/2022

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: 02/16/2022
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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