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

Model Number WCD 4000

Device Problems False Alarm (1013); Break (1069); Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (check belt messages, damaged connector, false asystole messages) was confirmed.Upon investigation the electrode belt failed a therapy electrode recognition test.The cause for the failure was isolated to an open pulse wire in the trunk cable.The root cause for the open wire was excessive force.There was no death or adverse event associated with the electrode belt malfunction.

Event Description

03/15/2021-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 (b)(6) 2018.Acknowledgements 1, 2, and 3 could not be located.A us distributor returned electrode belt sn (b)(4) and reported that the patient experienced "check therapy pad" messages, false asystole alarms, and that it 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: 11490111
• MDR Text Key: 244158888
• Report Number: 3008642652-2018-08801
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• 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