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

Model Number WCD 4000

Device Problem Failure to Charge (1085)

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

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of battery charger sn (b)(4) has been completed.The reported problem (does not charge battery packs) was confirmed.As received, the charger would not charge a test battery pack.Upon evaluation, there was liquid contamination on the battery board and there was a bga failure at the u104 and u1003 processors.The cause of the inability to charge the battery packs is the contamination and bga failure.The cause of the contamination is liquid ingress of an unknown contaminant.The cause of the bga failure cannot be positively identified.The root cause of the inability to charge the battery packs cannot be distinguished between the contamination, and bga failure.No adverse events occurred as a result of the defective charger.

Event Description

On 10/14/2020: 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 returned a charger indicating that it was unable to charge a test battery pack.

• 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: 10677005
• MDR Text Key: 211513198
• Report Number: 3008642652-2018-00713
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005029
• UDI-Public: 00855778005029
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10A0985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• 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