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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 04/15/2022

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away on 4/15/2022 while reportedly wearing the lifevest.The patient received one inappropriate treatment.  the device was started up at 23:38:03 on 4/13/2022.At 06:20:19 on 4/15/2022, an arrhythmia was detected.Ecg shows asystole with intermittent cardiac activity, unconducted p waves and cpr/motion artifact.The rhythm transitions to sinus bradycardia @ 15 bpm with unconducted p waves and cpr/motion artifact.At 21:57:52, the patient received the inappropriate treatment.Rhythm at the time of treatment was sinus bradycardia @ 15 bpm with unconducted p waves and cpr/motion artifact.Post shock rhythm was sinus rhythm @ 60 bpm with cpr/motion artifact.The device was shut down at 07:26:48 on 4/15/2022.The patient passed away on 4/15/2022.

Manufacturer Narrative

Device evaluation of the monitor has been completed.During the incoming functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, 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.The belt has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.

• 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: pavan savio ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 14601140
• MDR Text Key: 293340798
• Report Number: 3008642652-2022-05068
• 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: 05/17/2022

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: 05/05/2022
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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