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 Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: device evaluation of battery charger/modem (b)(4) has been completed.The reported problem (burning smell) has been confirmed.Upon investigation, the battery charger/modem was unable to charge a battery pack.The cause for the failure was contamination on the battery pca and a shorted q1 current-controlling transistor on the bedside pca.The shorted transistor was caused by the contamination.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.Device evaluation of battery (b)(4) has been completed.The reported problem (power surges) has been confirmed.Upon investigation, the battery was unable to recharge or power on a monitor.The f1 fuse was open.The cause for the open fuse was excessive current.The root cause for the excessive current was unable to be positively identified.No adverse event resulted from the defective battery.

Event Description

A us distributor reported that a patient's charger was emitting a burning smell and the battery was on the charger during power surges.

• 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: 7507061
• MDR Text Key: 108144590
• Report Number: 3008642652-2018-04167
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• 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: 04/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2015
• 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