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); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 09/07/2021

Event Type  Death  

Manufacturer Narrative

Monitor sn (b)(4) and electrode belt sn (b)(4) were returned to the distributor.The distributor downloaded the software flag files for zoll manufacturing to review, in accordance with procedures recommended by zoll manufacturing.The distributor did not indicate a product malfunction.  zoll manufacturing evaluated the downloaded software flag files on the day of the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.During the incoming functional testing at the distributor, 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 of the device.Device manufacture date: monitor: 01/12/2021.Belt: 02/11/2013.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest in the hospital on (b)(6) 2021.It was reported that hospital staff was present with the patient at the time of the event.Review of the patient's download data indicates the patient received one appropriate shock and two inappropriate shocks in response to oversensing of low amplitude cardiac signal and cpr/motion artifact on the date of passing.The device was started up at 20:26:52 on (b)(6) 2021.The patient's rhythm degraded to vf with motion artifact at 01:33:38 on (b)(6) 2021.The patient received the appropriate shock at 01:37:02.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for six seconds before transitioning to sinus bradycardia at 40 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient was in sinus bradycardia at 40 bpm with tall t waves between 01:38:12 and 01:40:07.The patient was in sinus bradycardia at 30 bpm with low amplitude cardiac signal between 02:01:48 and 02:04:46.The patient's rhythm was obscured by cpr/motion artifact at 02:10:17.The patient received the first inappropriate shock at 02:11:03.The patient's rhythm at the time of the shock and post-shock rhythm were asystole with cpr/motion artifact.The patient received the second inappropriate shock at 02:14:11.The patient's rhythm at the time of the shock and post-shock rhythm were asystole with cpr/motion artifact.The device was shutdown at 02:14:17 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: 12617258
• MDR Text Key: 275966784
• Report Number: 3008642652-2021-09017
• 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: 10/12/2021

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
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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