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

Model Number WCD 4000

Device Problems False Alarm (1013); Defective Component (2292)

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

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (service code 204, false asystole alarms) has been confirmed.Upon investigation the electrode belt was unable to communicate with a monitor.The cause for the failure was isolated to an open yellow (pgnd) wire in the trunk cable.The trunk cable connector was cracked.The root cause for the open wire and damaged connector was excessive force.There was no death or adverse event associated with the belt malfunction.

Event Description

03/22/2021- resubmitting this mdr as part of an internal audit where the electronic 3500a pdf form could not be located.The internal audit indicates that the electronic 3500a form, within the esubmitter application, was created on 12/17/2018.Acknowledgements 1, 2, and 3 could not be located.A us distributor reported that a patient was receiving a service code 204 (belt/monitor unusable) and false asystole alarms.

• 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: 11544295
• MDR Text Key: 243948786
• Report Number: 3008642652-2018-10679
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• 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: 11/19/2018
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2013
• 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