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); Loss of consciousness (2418); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 09/22/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of the 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 while wearing the lifevest.It was reported that the patient was in the hospital and unconscious with staff present prior to passing.Review of the patient's download data revealed that prior to passing, the patient experienced one inappropriate treatment from the lifevest followed by one appropriate treatment from the lifevest.At 05:00:53, the patient received the inappropriate treatment from the lifevest.The patient's rhythm at the time of the treatment was asystole with cpr and motion artifact, and the post-shock rhythm was also asystole with cpr and motion artifact.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient remained in asystole with cpr and motion artifact until 05:17:38, when the rhythm became vt at 210 bpm with motion artifact.At 05:18:08, the patient received the appropriate treatment from the lifevest.The patient's rhythm at the time of the treatment was vt at 190 bpm with motion artifact, and the post-shock rhythm was asystole for 5 seconds transitioning to severe bradycardia at 10 bpm with cpr/motion artifact and lead falloff.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The response buttons were not pressed during the event.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: 12682415
• MDR Text Key: 277929231
• Report Number: 3008642652-2021-09370
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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: 10/04/2021
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2013
• 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