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); Ventricular Fibrillation (2130); Asystole (4442)

Event Date 09/18/2021

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) 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 initially at home but was transported to the hospital where they later passed away.Review of the patient's download data revealed that prior to passing, the patient received 7 appropriate treatments and 2 inappropriate treatments from the lifevest.At 07:51:13, the patient received the first treatment while their rhythm was vt at 250 bpm.The treatment was appropriate.The post-shock rhythm was vt at 215 bpm with a sinus beat.The rhythm then transitioned to vt at 230 bpm.At 07:52:02, the patient received the second treatment while their rhythm was vt at 250 bpm.The treatment was appropriate.The post-shock rhythm was one sinus beat transitioning to vt at 270 bpm.At 07:52:24, the patient received the third treatment while their rhythm was vt at 280 bpm.The treatment was appropriate.The post-shock rhythm was sinus rhythm at 70 bpm transitioning to vt at 280 bpm.At 07:52:58, the patient received the fourth treatment while their rhythm was vt at 280 bpm.The treatment was appropriate.The post-shock rhythm was sinus beats with pauses degrading to vf.At 07:53:19, the patient received the fifth treatment while their rhythm was vt at 280 bpm.The treatment was appropriate.The post-shock rhythm was sinus rhythm at 60 bpm slowing to severe bradycardia at 10 bpm with pvc's degrading to vf.At 07:53:54, the patient received the sixth treatment while their rhythm was vf.The treatment was appropriate.The post-shock rhythm was sinus bradycardia at 40 bpm pauses and nsvt.At 08:33:10, the patient received the seventh treatment while their rhythm was asystole with intermittent cardiac activity and cpr/motion artifact.The treatment was inappropriate.The post-shock rhythm was asystole for 2 seconds transitioning to vt at 110 bpm.At 08:35:01, the patient received the eighth treatment while their rhythm was vf with cpr and motion artifact.The treatment was appropriate.The post-shock rhythm was asystole with intermittent cardiac activity and cpr/motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.At 08:38:52, the patient received the ninth treatment while their rhythm was obscured by cpr and motion artifact.The treatment was inappropriate.The post-shock rhythm was asystole with intermittent cardiac activity and cpr/motion artifact/lead fall off.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The response buttons were pressed throughout the event, but not immediately prior to shock delivery.The response buttons functioned appropriately.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: 12682414
• MDR Text Key: 277938718
• Report Number: 3008642652-2021-09369
• 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: 10/06/2021
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2013
• 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