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

Model Number WCD 4000

Device Problem Signal Artifact/Noise (1036)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 11/15/2021

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.Per clinical review of the continuous ecg recording, the device was started up at 04:46:19 on (b)(6) 2021.From 20:30:45 to 23:55:18 on (b)(6) 2021, the patient's rhythm was intermittently af with rvr at 150 bpm with pvc's motion artifact and varying hr.At 16:26:39 on 11/15/2021, patient's rhythm was sinus bradycardia at 50 bpm that degraded into asystole.Per continuous ecg recording, cpr/motion artifact began at 16:27:49.From 16:27:56 to 16:38:08, the patient's rhythm was intermittently asystole with cpr/motion artifact.From 16:48:02 to 16:55:04 on (b)(6) 2021, the patient's rhythm was vt at 160 bpm.Both channels were obscured by artifact and falloff which prevented the lifevest from treating the patient.At 16:55:04 on (b)(6) 2021, the electrode belt was disconnected.

Manufacturer Narrative

Device evaluation of the monitor has been completed.During the incoming functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz 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.

Manufacturer Narrative

Device evaluation of the monitor has been completed.During the incoming functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz 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.

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.Per clinical review of the continuous ecg recording, the device was started up at 04:46:19 on (b)(6) 2021.From 20:30:45 to 23:55:18 on (b)(6) 2021, the patient's rhythm was intermittently af with rvr at 150 bpm with pvc's motion artifact and varying hr.At 16:26:39 on 11/15/2021, patient's rhythm was sinus bradycardia at 50 bpm that degraded into asystole.Per continuous ecg recording, cpr/motion artifact began at 16:27:49.From 16:27:56 to 16:38:08, the patient's rhythm was intermittently asystole with cpr/motion artifact.From 16:48:02 to 16:55:04 on (b)(6) 2021, the patient's rhythm was vt at 160 bpm.Both channels were obscured by artifact and falloff which prevented the lifevest from treating the patient.At 16:55:04 on (b)(6) 2021, the electrode belt was disconnected.

• 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: 13592999
• MDR Text Key: 286080671
• Report Number: 3008642652-2022-01989
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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: 12/07/2021
• Date Manufacturer Received: 01/26/2022
• 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