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

Model Number WCD 4000

Device Problem Signal Artifact/Noise (1036)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

A us distributor contacted zoll to report that a german patient received a treatment from the lifevest.Review of the patient's download data revealed that the patient's rhythm was vf with motion artifact.The monitor delivered a treatment to the patient and immediately reset after delivering the pulse.The monitor restarted and the patient's rhythm was sinus bradycardia.The patient remained in the hospital after the event and has ended use of the lifevest to receive an icd.

Manufacturer Narrative

Device evaluation of monitor has been completed.The reported problem (abnormal shutdown/treatment) was confirmed.Upon evaluation the monitor passed incoming functionality testing.A review of download data indicates that the monitor reset after delivering a pulse to the patient in the field.The root cause for the reset was unable to be positively identified.No adverse event resulted from the damaged monitor.

• 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: 13063337
• MDR Text Key: 284710141
• Report Number: 3008642652-2021-11223
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/24/2021
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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