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

Model Number WCD 4000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been competed.The reported problem (check te pad messages, discharge profile faults) was confirmed.As received, the monitor failed incoming testing, and produced service code 105 and service code 204.Upon evaluation, the q12 and q16 transistors were physically damaged.In addition, the inter-pca connectors j1000, j1002, and j1003 were defective.The cause for the failure is the defective components.In addition, there was extensive physical damage found to the monitor.The root cause of the defective components cannot be positively identified.No adverse events occurred as a result of the defective monitor.

Event Description

A u.S.Distributor returned monitor sn (b)(4), and reported that the device caused, "check therapy pad" messages, and discharge profile faults.

• 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: 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 10677007
• MDR Text Key: 211349154
• Report Number: 3008642652-2018-00726
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• 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: 12/21/2017
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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