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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

Patient Problems Bradycardia (1751); Tachycardia (2095); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 09/23/2021

Event Type  Death  

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 was returned and evaluated at the distributor.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 manufacture date: monitor 05/11/2015; belt 08/16/2011.

Event Description

A us distributor contacted zoll to report that a (b)(6) patient passed away while wearing the lifevest in the hospital overnight between (b)(6) 2021 and (b)(6) 2021.Review of the patient's download data indicates the patient received one appropriate shock and one inappropriate shock in response to oversensing of low amplitude cardiac signal and motion artifact on the date of passing.The device was started up at 14:26:04 on (b)(6) 2021.The patient was in sinus rhythm at 80 bpm with pvc's and pac's at the time of the device shutdown at 14:56:07.The device was started up again at 18:30:02.The patient was in sinus rhythm at 80 bpm with pvc's at 18:41:51.The patient's rhythm then degraded to vt at 290 bpm.The patient received the appropriate shock at 18:42:24.The patient's rhythm at the time of the shock was vt at 280 bpm.The patient's post-shock rhythm was obscured by motion artifact before degrading to asystole.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the inappropriate shock at 18:42:55.The patient's rhythm at the time of the shock was asystole with motion artifact.The patient's post-shock rhythm was asystole for 20 seconds, transitioning to severe bradycardia at 10 bpm.The patient was last seen in sinus tachycardia at 120 bpm with nsvt at 18:44:58 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12705804
• MDR Text Key: 278624135
• Report Number: 3008642652-2021-09504
• 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: 10/27/2021

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: 10/20/2021
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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