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

Model Number WCD 4000

Device Problem Device Emits Odor (1425)

Patient Problem No Information (3190)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: device evaluation of charger (b)(4) and battery (b)(4) has been completed.The reported problem (burning smell) was confirmed.As received, the battery was unable to power on a monitor or charge and the charger was unable to charge a battery.Upon investigation, the battery pca had contamination.The battery contamination caused the nickel strips on the pca to be shorted, which caused thermal damage to the charger's battery and bedside pcas.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 charger and battery.

Event Description

A us distributor contacted zoll to report that there was a burning smell coming from a patient's charger.

• 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: 7561597
• MDR Text Key: 109977090
• Report Number: 3008642652-2018-05010
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 05/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2014
• 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