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

Model Number WCD 4000

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.Upon investigation the monitor was unable to communicate with an electrode belt.The monitor's electrode belt connector was broken free from the monitor enclosure and was missing, damaging wires within the connector.The root cause for the damaged connector was excessive force.No adverse event resulted from the defective monitor.Device evaluation of electrode belt sn (b)(4) has been completed.Upon investigation the monitor's belt connector was stuck to the trunk cable connector.The root cause for the stuck trunk cable connector was physical abuse.No adverse event resulted from the defective electrode belt.Manufacture dates.Monitor: 1/12/2016.Electrode belt: 3/31/2015.

Event Description

During servicing of a monitor and electrode belt which were returned for investigation into an unrelated issue, a reportable malfunction was found.Monitor sn (b)(4) and electrode belt sn (b)(4) failed incoming functional testing.

• 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: 10456932
• MDR Text Key: 204895073
• Report Number: 3008642652-2020-07060
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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