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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/07/2020

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) has not been returned from the field.It was reported that the belt was cut off of the patient at the hospital and thrown out.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.Manufacture dates: monitor 1/29/2014.Electrode belt 10/22/2018.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020 while wearing the lifevest.Ems attempted to resuscitate the patient prior to passing.Clinical review of the patient's continuous ecg recordings revealed that prior to passing, the patient received four external non-lifevest defibrillations while wearing the lifevest, and one appropriate treatment from the lifevest.Per review of the continuous ecg recordings, at 12:00:04 pm on (b)(6) 2020, the patient received the first non-lifevest defibrillation.The patient's rhythm at the time of the external defibrillation was ventricular tachycardia (vt) at 200 bpm with cpr and motion artifact and the post-shock rhythm was obscured by cpr and motion artifact.The patient was in vt for 8 seconds before receiving the external defibrillation.At 12:02:27 pm, the patient received the second non-lifevest defibrillation.The patient's rhythm at time of external defibrillation was vt at 200 bpm with cpr and motion artifact and the post-shock rhythm was obscured by cpr and motion artifact.The patient was in vt for 10 seconds before receiving the external defibrillation.At 12:14:56 pm, the patient received a third non-lifevest defibrillation.The patient's rhythm at time of external defibrillation was vt at 190 bpm with cpr and motion artifact, and the post-shock rhythm was sinus tachycardia at 110 bpm with cpr and motion artifact.The patient was in vt for 3 second prior to receiving the external defibrillation.The patient then received a fourth non-lifevest defibrillation.The patient's rhythm at time of external defibrillation was sinus tachycardia at 110 bpm with cpr and motion artifact, and the patient's post-shock rhythm was obscured by cpr and motion artifact.All external defibrillations occurred within 10 seconds of the vt arrhythmia onset.The lifevest typically requires 60 seconds of sustained vt to deliver a treatment shock.At 12:15:49 pm, an arrhythmia was declared by the lifevest.The patient's rhythm was vt at 180 bpm.Cpr and motion artifact were also observed on the patient's ecg recording.The patient received an appropriate treatment from the lifevest at 12:16:25 pm.The post-shock rhythm was obscured by cpr and motion artifact.The patient's electrode belt was disconnected at 12:17:07 while the rhythm was still obscured by cpr and motion artifact.It was reported that the patient's electrode belt was cut off and discarded at the hospital.This event is being reported out of an abundance of caution as the post-shock rhythm of the lifevest treatment is not known.

• 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: 11100434
• MDR Text Key: 224532497
• Report Number: 3008642652-2020-11642
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 12/01/2020
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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