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

Model Number WCD 4000

Device Problems False Positive Result (1227); Loose or Intermittent Connection (1371)

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

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (connector damaged/false asystole event) has been confirmed.Upon investigation the trunk cable connector was physically damaged and the electrode belt was unable to securely connect to a monitor.The root cause for the damaged connector was excessive force.No adverse event resulted from the defective electrode belt.

Event Description

A us distributor returned a patient's electrode belt and reported that the electrode belt connector was not staying latched, and the patient was experiencing false asystole events.

• 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: mary ward ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10031336
• MDR Text Key: 190186463
• Report Number: 3008642652-2020-03859
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005135
• UDI-Public: 00855778005135
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• 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: 10A1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• 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