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); Pacing Problem (1439)

Patient Problems Bradycardia (1751); Loss of consciousness (2418); Shock from Patient Lead(s) (3162)

Event Date 08/28/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, 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 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.Electrode belt sn (b)(4) was returned to the manufacturer and the evaluation is underway.Device evaluation included review of 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.The software flag files did not suggest a device malfunction that would contribute to the patient's passing.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021.It was reported that the patient was found unresponsive and was taken to the hospital.Review of the patient's download data revealed that prior to passing, the patient received 3 inappropriate treatments from the lifevest.At 17:35:29, the patient received the first treatment from the lifevest.The patient's rhythm at the time of the treatment was a paced rhythm at 40 bpm with intermittent ventricular response and motion artifact, and the post-shock rhythm was also a paced rhythm at 40 bpm with intermittent ventricular response and motion artifact.At 17:37:52, the patient received the second treatment from the lifevest.The patient's rhythm at the time of the treatment was a paced rhythm at 40 bpm with intermittent ventricular response and motion artifact, and the post-shock rhythm was also a paced rhythm at 40 bpm with intermittent ventricular response and motion artifact.At 17:39:17, the patient received the second treatment from the lifevest.The patient's rhythm at the time of the treatment was a paced rhythm at 40 bpm with intermittent ventricular response and motion artifact, and the post-shock rhythm was also a paced rhythm at 40 bpm with intermittent ventricular response and motion artifact.18:22:17, the electrode belt was disconnected.Review of the patient's download data shows that the patient was in a paced rhythm at 60 bpm with pvc's, cpr/motion artifact, pacemaker spike, and electrode lead fall off at the time of electrode belt disconnection.Multiple counting and oversensing of cardiac activity contributed to the false detections.The response button were not pressed during the event.It was reported that the lifevest was removed from the patient and the resuscitation attempts were made on the patient.There is no indication that a device malfunction caused or contributed to the patient's passing.

• 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: 12598834
• MDR Text Key: 275443261
• Report Number: 3008642652-2021-08904
• 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: 10/08/2021

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: 09/14/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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