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 Problems Bradycardia (1751); Idioventricular Rhythm (1923); Loss of consciousness (2418)

Event Date 10/30/2021

Event Type  Death  

Manufacturer Narrative

The electrode belt and the monitor have not yet been recovered from the field.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 while wearing the lifevest.It was reported that the patient was initially at home prior to passing when they lost consciousness.Review of the patient's download data revealed that prior to passing, the patient received one inappropriate treatment from the lifevest.At 00:20:12, the patient received the treatment.The patient's rhythm at the time of the treatment was obscured by motion artifact.The post-shock rhythm was cpr/motion artifact the rhythm transitioning to an idioventricular rhythm at 30 bpm.At 00:23:21, the patient's rhythm was idioventricular rhythm at 30 bpm with cpr/motion artifact.The rhythm then transitioned to severe bradycardia/bradycardia from 10-20 bpm with cpr/motion artifact.The electrode belt was disconnected at 00:23:35.Motion artifact contributed to the false detection.The response buttons were not pressed during the event.It was reported that the patient's spouse called ems and the patient passed away on the way to the hospital.There is no indication that a device malfunction caused or contributed to the patient's passing.

Manufacturer Narrative

Supplemental report 1/12/2022: device evaluation of the monitor 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.Device evaluation of electrode belt has been completed.Upon investigation the cable connecting the distribution node (dn) to the rear therapy electrodes was pulled from the strain relief, damaging wires in the cable.The root cause for the strained cable was excessive force.The electrode belt and the monitor have not yet been recovered from the field.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 while wearing the lifevest.It was reported that that the patient was initially at home prior to passing when they lost consciousness.Review of the patient's download data revealed that prior to passing, the patient received one inappropriate treatment from the lifevest.At 00:20:12, the patient received the treatment.The patient's rhythm at the time of the treatment was obscured by motion artifact.The post-shock rhythm was cpr/motion artifact the rhythm transitioning to an idioventricular rhythm at 30 bpm.At 00:23:21, the patient's rhythm was idioventricular rhythm at 30 bpm with cpr/motion artifact.The rhythm then transitioned to severe bradycardia/bradycardia from 10-20 bpm with cpr/motion artifact.The electrode belt was disconnected at 00:23:35.Motion artifact contributed to the false detection.The response buttons were not pressed during the event.It was reported that the patient's spouse called ems and the patient passed away on the way to the hospital.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: 12930020
• MDR Text Key: 281729016
• Report Number: 3008642652-2021-10661
• 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,Followup
• Report Date: 01/12/2022

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?: Yes
• 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: 12/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• 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