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

Model Number WCD 4000

Device Problems Defective Alarm (1014); Break (1069); Unexpected Shutdown (4019)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem ("add gel/replace belt" messages) has been confirmed.Upon investigation the cable connecting the distribution node (dn) to the rear therapy electrodes was pulled from the strain relief, damaging wires in the cable and causing the reported "add gel/replace belt" messages.The root cause for the strained cable was excessive force.No adverse events occurred from the defective electrode belt.Device evaluation of monitor sn (b)(4) has been completed.The reported problem (abnormal shutdowns, gong alerts) has been confirmed.Upon investigation the monitor failed a baseline.The cause for the failure was isolated to a defective c655 capacitor and u612 inverting charge pump on the computer/analog pca.The root cause for the defective u612 component could not be positively identified.Root cause investigation of similar failures has determined that damage to the electrode belt cables can cause damage to the u612 inverting charge pump.The root cause for the defective c655 was unable to be positively identified.No adverse events occurred from the defective electrode belt.Manufacture dates: belt sn (b)(4) - 12/30/2015, monitor sn (b)(4) - 01/12/2016.

Event Description

A us distributor reported that a patient's electrode belt was damaged and that a patient was receiving gong alerts and abnormal shutdowns.

• 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: anna beatty ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11130657
• MDR Text Key: 226852419
• Report Number: 3008642652-2021-00053
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• 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