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

Model Number WCD 4000

Device Problems Defective Alarm (1014); Defective Component (2292)

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

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (gong alarms, belt connection) has been confirmed.Upon investigation the electrode belt failed an ecg fall-off test.The cause for the failure was isolated to an open white (drvn_gnd) wire in the trunk cable.The trunk cable showed signs of physical abuse.The root cause for the open wire and the strained cable was excessive force.There was no death or adverse event associated with the belt malfunction.

Event Description

04/05/2021-resubmitting this mdr as part of an internal audit where the electronic 3500a pdf form was located, and acknowledgements 1, 2, and 3 could not be located.A us distributor reported that a patient was receiving frequent gong alarms and that the patient's electrode belt had a damaged connector.

• 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: 11614997
• MDR Text Key: 245101642
• Report Number: 3008642652-2019-02088
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• 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: 02/22/2019
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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