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); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 10/25/2021

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away in the hospital on (b)(6) 2021.Review of the patient's download data indicates the patient received 4 appropriate shocks on the date of passing and 1 inappropriate shock.Per clinical review of the patient's ecg recordings, the device was started up at 01:14:33 on (b)(6) 2021.The patient was in sinus rhythm at 90 bpm with motion artifact at 04:24:39.The patient was in sinus rhythm at 80 bpm with motion artifact and nsvt at 15:14:43.The patient's rhythm transitioned to vt at 240 bpm at 15:50:16.The patient received the appropriate shock at 15:50:51.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm with pvc's.The patient was then seen in sinus rhythm at 70 bpm with pvc's and nsvt, transitioning to sinus tachycardia at 100 bpm at 16:08:09.At 17:31:28 on (b)(6) 2021, the patient received the second appropriate treatment from the lifevest during vt at 240 bpm.The post-shock rhythm was sinus bradycardia at 40 bpm.At 18:03:17, the patient received the third appropriate treatment from the lifevest during vt at 260 bpm.The post-shock rhythm was sinus bradycardia at 30 bpm transitioning to sinus rhythm at 80 bpm.At 18:24:47, the patient received the fourth appropriate treatment from the lifevest during vt at 250 bpm.The post-shock rhythm was sinus bradycardia at 40 bpm with pvcs transitioning to sinus tachycardia at 100 bpm.At 02:04:09 on (b)(6) 2021, the patient received an inappropriate treatment from the lifevest.The patient's rhythm at the time of the treatment was asystole, and the post-shock rhythm was asystole with motion artifact.Oversensing of cardiac signal contributed to the false detection.The response buttons were not pressed during the event.The patient remained in asystole with motion artifact until the electrode belt was disconnected at 02:05:19 on (b)(6) 2021.

Manufacturer Narrative

The monitor and electrode belt were returned and evaluated at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.The software flag files did not suggest a device malfunction.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.

• 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: mary ward ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12926735
• MDR Text Key: 281691082
• Report Number: 3008642652-2021-10588
• 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: 12/01/2021

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?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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; Other