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)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 11/03/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of the monitor and electrode belt has been completed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, 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 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.Device manufacture date: monitor 08/13/2015, belt 11/17/2015.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021.Review of the patient's download data indicates the patient received two inappropriate shocks in response to oversensing of low amplitude cardiac signal and cpr/motion artifact on the date of passing.The device was started up at 08:55:27 on (b)(6) 2021.The patient was in an idioventricular rhythm at 40 bpm degrading to asystole at approximately 19:53:55.The patient was in asystole with cpr/motion artifact and intermittent cardiac activity between 19:54:23 and 20:02:34.The patient's rhythm then transitioned to an idioventricular rhythm at 60 bpm at approximately 20:03:04.The patient's rhythm degraded to asystole with cpr/motion artifact and intermittent cardiac activity at 20:04:04.The patient's rhythm then transitioned to an idioventricular rhythm at 50 bpm, degrading to severe bradycardia at 10 bpm by 20:30:41.The patient's rhythm degraded to asystole with cpr/motion artifact at 20:33:06 before returning to an idioventricular rhythm at 50 bpm with cpr/motion artifact at 20:35:45.The patient received the first inappropriate shock at 20:41:53.The patient's rhythm at the time of the shock was an idioventricular rhythm at 80 bpm with cpr/motion artifact.The patient's post-shock rhythm was asystole transitioning to an idioventricular rhythm at 35 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the second inappropriate shock at 20:42:23.The patient's rhythm at the time of the shock was an idioventricular rhythm at 35 bpm.The patient's post-shock rhythm was asystole.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient was in an idioventricular rhythm at 90 bpm with motion artifact and pvc's at 20:44:49.The patient's rhythm transitioned to an idioventricular rhythm at 30 bpm with motion artifact by 20:45:37.The patient was last seen in an idioventricular rhythm at 20 bpm.The electrode belt was disconnected at 20:49:12 on (b)(6) 2021.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13009367
• MDR Text Key: 282262271
• Report Number: 3008642652-2021-10959
• 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: 12/14/2021

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: 11/19/2021
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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