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

Model Number WCD 4000

Device Problem Failure to Power Up (1476)

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

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of battery sn (b)(4) has been completed.The reported problem (will not power on monitor) has been confirmed.As received, the battery was unable to power on a monitor or charge.Upon evaluation, the battery pack tri-cells were depleted.The battery did not last 24 hours before being discharged.The root cause of the depleted cells was unable to be positively identified.No adverse events occurred as a result of the defective battery.

Event Description

(b)(6) 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 contacted zoll to report that a battery was unable to power on a monitor.

• 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: 10676997
• MDR Text Key: 211505194
• Report Number: 3008642652-2018-00699
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005036
• UDI-Public: 00855778005036
• 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: 10A0989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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