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); Idioventricular Rhythm (1923); Tachycardia (2095); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 12/08/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor has been completed.Upon investigation the monitor was not properly producing a driven ground signal.The cause for the failure was isolated to an open r781 driven ground resistor on the computer/analog board.An open r781 is consistent with a patient receiving external defibrillations while wearing the lifevest.The electrode belt has 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 at the hospital and lost consciousness prior to passing.Review of the patient's download data revealed that prior to passing, the patient experienced three inappropriate treatments from the lifevest.At 15:36:18, the patient received the first treatment.The patient's rhythm at the time of the treatment was an idioventricular rhythm at 30 bpm, the post-shock rhythm was an idioventricular rhythm at 40 bpm.At 15:36:18, the patient received the second treatment.The patient's rhythm at the time of the treatment was an idioventricular rhythm at 40 bpm, the post-shock rhythm was an idioventricular rhythm at 40 bpm.At 15:37:49, the patient received the third treatment.The patient's rhythm at the time of the treatment was an idioventricular rhythm at 40 bpm, the post-shock rhythm was an idioventricular rhythm at 40 bpm.Double counting, oversensing of low amplitude cardiac signal, and cpr/motion artifact contributed to the false detection.Per clinical review of the patient's continuous ecg recordings, at 15:42:40, the patient was in asystole with cpr and motion artifact.The rhythm then degrades to vt at 250 bpm with varying amplitudes, cpr/motion artifact, and electrode lead fall off.At 15:47:47, the patient received a non-lifevest defibrillation.The patient's rhythm at time was asystole with cpr artifact.Post shock rhythm was obscured by cpr artifact.Varying amplitudes, cpr/motion artifact, and electrode lead fall off prevented the lifevest from treating the patient during this time.The rhythm then transitioned to sinus bradycardia/sinus rhythm from 40-70 bpm until the electrode belt was disconnected at 16:00:31.It was reported that the lifevest was removed by hospital staff so that cpr could be performed.

• 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: 13260399
• MDR Text Key: 283848783
• Report Number: 3008642652-2022-00541
• 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: 01/13/2022

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?: 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: 12/15/2021
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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): Other; Death