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 12/24/2021

Event Type  Death  

Manufacturer Narrative

The electrode belt and monitor have been returned and the evaluation is underway.The last device downloaded flag data does not indication a device malfunction.

Event Description

A us distributor contacted zoll to report that a patient passed away at home while wearing the lifevest on (b)(6) 2021.Review of the download data, indicates the patient received one inappropriate treatments in response to cpr/motion artifact.At 13:44:03, the patient was in sinus bradycardia at 20 bpm degrading to asystole.At 16:51:28, the patient received an inappropriate treatment.The patient's rhythm at the time of the treatment event was asystole with intermittent cardiac activity with cpr/motion artifact.The patient's post-shock rhythm was asystole with intermittent cardiac activity with cpr/motion artifact and electrode lead falloff.The electrode belt was disconnected at 17:59:53.The patient passed away on (b)(6) 2021 at approximately 05:29 pm.There is no indication that the inappropriate treatment caused or contributed to the patient's passing as the patient was in a non-life-sustaining rhythm prior to the treatment.

• 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: steven kyle ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13427951
• MDR Text Key: 284909812
• Report Number: 3008642652-2022-01172
• 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: 02/01/2022

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: 01/19/2022
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2018
• 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