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 Dizziness (2194); Loss of consciousness (2418)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (abnormal shutdown/patient treatment) was confirmed.Upon evaluation the monitor passed incoming functionality testing.A review of download data indicates that the monitor reset immediately after delivering a pulse while the patient was in a treatable rhythm.The root cause for the reset was isolated to noise originating from the defibrillator pca high-voltage capacitors and propagating on the main battery wire on the monitor c/a board.No adverse event resulted from the monitor malfunction.

Event Description

A us distributor contacted zoll to report that a french patient was treated by the lifevest.It was reported that the patient was at home and sitting on his couch with his wife present at the time of the event.The patient reportedly got dizzy and lost consciousness before receiving the treatment.Review of the patient's download data shows that the patient was in sinus rhythm at 60 bpm degrading to vt at 290 bpm further degrading to vf with intermittent response button use starting at 6:42:27 pm.Review of the patient's download flag files shows that the lifevest delivered a treatment at approximately 6:45:53 pm, and reset after delivering the shock.The patient's wife witnessed the treatment and reportedly initiated cpr and called ems.The patient was taken to the hospital after the event and has ended use of the lifevest due to receiving bypass surgery.There is no indication of any death or serious injury as a result of this 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: 9285788
• MDR Text Key: 176036559
• Report Number: 3008642652-2019-08966
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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 Age: 67 YR