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

Model Number WCD 4000

Device Problem Device Stops Intermittently (1599)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (abnormal shutdowns) was confirmed.Upon evaluation, the u409 and u413 can bus controllers (belt communications) were not producing an output.The cause of the abnormal shutdowns is the defective u409 and u413 controllers.The root cause of the defective controllers cannot be positively identified.No adverse event resulted from the defective monitor.

Event Description

A us distributor contacted zoll to report that a patient's device was experiencing abnormal shutdowns.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5385748
• MDR Text Key: 36672870
• Report Number: 3008642652-2016-00313
• Device Sequence Number: 1
• Product Code: MVK
• 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,study,user facili
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• 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: 12/22/2015
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2012
• 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