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

Model Number WCD 4000

Device Problems Loose or Intermittent Connection (1371); Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed at the distributor.The reported problem (abnormal shutdowns, damaged connector) has been confirmed.Upon evaluation of the electrode belt, the latches on the trunk cable connector were damaged, creating an insecure connection with the monitor.The cause of the abnormal shutdowns was the damaged connector on the electrode belt.The root cause for the damaged connector was excessive force.No adverse event resulted from the defective electrode belt.

Event Description

A us distributor reported that a patient was experiencing abnormal shutdowns and that the belt connector would not stayed latched.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: anna beatty ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 9831419
• MDR Text Key: 186006919
• Report Number: 3008642652-2020-01430
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005012
• UDI-Public: 00855778005012
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 10A0987
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2018
• 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