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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Structural Problem (2506); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

A us distributor reported that a monitor's response buttons are intermittent and an electrode belt ecgs were non-functional.

Manufacturer Narrative

Device evaluation of monitor has been completed.The reported problem (response buttons intermittent) was confirmed due to the rear response button being contaminated.The cause of the inability to activate the monitor is the contaminated response button.The root cause of the contaminated response button is liquid ingress of an unknown contaminant.Lifevest patient training materials have been updated as a reminder not to expose lifevest electronic components to liquid.No adverse event resulted from the damaged monitor.Device evaluation of electrode belt has been completed.The reported problem (adjust belt or check belt messages) has been confirmed.Upon investigation the electrode belt unable to complete an ecg fall-off test.The cable connecting ecg "c" and ecg "d" was pulled from the strain relief, damaging the j501 connector on the distribution node pca.The root cause for the strained cable was excessive force.No adverse event resulted from the damaged belt.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 18968381
• MDR Text Key: 338486488
• Report Number: 3008642652-2024-03274
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• 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: 03/25/2024

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: LIFEVEST WCD 4000 SYSTEM
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 03/25/2024
• 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