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 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of battery charger sn (b)(4) has been completed.The reported problem (not powering on) has been confirmed.Upon investigation the battery charger/modem was unable to fully power on.The charger exhibited a flash memory failure at bga components u102 and u105 on the c/a board.The root cause for the flash memory failure could not be positively identified.No adverse event resulted from the defective battery charger.

Event Description

A us distributor reported that a patient's battery charger would not properly power on.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: anna beatty ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10416171
• MDR Text Key: 203825563
• Report Number: 3008642652-2020-07106
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• 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: 10A0985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2012
• 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