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 Insufficient Information (4580)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of battery pack sn (b)(4) has been completed.The reported problem (will not power on monitor) was confirmed.As received, the battery pack was unable to power a test monitor and charge.Upon evaluation, the nickel busbar tabs at the p2 and p4 pads were loose.The cause of the non-functional battery pack is the loose busbar.The root cause of the loose busbar cannot be positively identified.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.The battery pca and cells were contaminated.The root cause for the contamination was ingress of an unknown liquid.Lifevest patient training materials have been updated as a reminder not to expose the lifevest electronic components to liquids.No adverse event resulted from the defective batteries.

Event Description

A us distributor reported that a patient's batteries would not 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: brooke arnold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11097974
• MDR Text Key: 225283202
• Report Number: 3008642652-2020-11609
• 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: 12/30/2020

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: 12/01/2020
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/30/2020
• 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