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

Model Number WCD 4000

Device Problems Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)

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

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of battery charger/modem sn (b)(4) has been completed.The reported problem (battery charger problem) 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, a shorted q1 current-controlling transistor, a shorted u13 cmos flash microcontroller, and a shorted d2 diode on the bedside pca.The damage to the diode, transistor, and microcontroller 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 battery charger/modem.

Event Description

A us distributor reported that a patient alleged that their battery charger "started beeping, and then there was a smell, and a string of smoke coming out of" the 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: brooke arnold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8659519
• MDR Text Key: 146691027
• Report Number: 3008642652-2019-03901
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• 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: 04/23/2019
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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