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

Model Number WCD 4000

Device Problems No Audible Alarm (1019); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Death (1802); Electric Shock (2554)

Event Date 11/29/2020

Event Type  Death  

Manufacturer Narrative

Electrode belt sn (b)(4) and monitor sn (b)(4) were returned to the manufacturer and the evaluation is currently 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 inappropriate treatment or patient's passing.Manufacture dates: monitor 12/19/2019, electrode belt 12/11/2019.

Event Description

A us distributor contacted zoll to report that a (b)(6) patient passed away in the hospital with a nurse present on (b)(6) 2020 while wearing the lifevest.Clinical review of the patient's download data revealed that prior to passing, the patient experienced two inappropriate treatments, and one appropriate treatment from the lifevest.The patient's nurse reportedly witnessed the first treatment and reported that there were no alarms.The device is currently being evaluated and alarm functionality will be confirmed.Per clinical review, at 23:29:39 on (b)(6) 2020, the patient received the first inappropriate treatment from the lifevest.The patient's rhythm at the time of the treatment was supraventricular tachycardia (svt) at 130 bpm, and the post-shock rhythm was atrial fibrillation (af) at 70 bpm.Motion artifact was also observed on the ecg following the shock.Approximately 7 hours later, at 06:45:44 on (b)(6) 2020, the patient received the second inappropriate treatment from the lifevest.The patient's rhythm at the time of the treatment was svt at 140 bpm, and the post-shock rhythm was af at 80 bpm transitioning to sinus rhythm at 80 bpm.Oversensing of amplitude during svt contributed to the rapid rate false detections.At 07:51:38 on (b)(6) 2020, the patient received an appropriate treatment from the lifevest.The patient's rhythm at the time of the treatment was ventricular tachycardia (vt) at 220 bpm with motion artifact and the post-shock rhythm was af at 80 bpm with motion artifact transitioning to bradycardia at 20 bpm with heart block (hb) and motion artifact.A non-treatable rhythm was declared by the lifevest at 07:52:21.It was reported by the patient's nurse that the patient passed away from asystole at an unknown time after the treatments on (b)(6) 2020.Asystole is considered a non-shockable, non-life sustaining rhythm.The response buttons were not pressed during the entire event.

• 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: 11100433
• MDR Text Key: 224534980
• Report Number: 3008642652-2020-11624
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 12/24/2020
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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): Death; Other