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

Model Number WCD 4000

Device Problem Device Inoperable (1663)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt (b)(4) has been completed.The reported problem (non-functional tes) has been 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 cable connecting the distribution node (dn) and ecg "b".The root cause for the open wire was excessive force.No adverse event resulted from the open pulse wire.

Event Description

A us distributor contacted zoll to report that an electrode belt had non-functional therapy electrodes.

• 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: gabrielle salazar ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7646992
• MDR Text Key: 112761758
• Report Number: 3008642652-2018-05714
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2013
• 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