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

Model Number WCD 4000

Device Problems Cut In Material (2454); Device Displays Incorrect Message (2591)

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

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (constant ongoing, exposed wires) was confirmed.As received, the monitor failed incoming testing.Upon evaluation, the belt receptacle was pulled from the monitor case, damaging the internal pulse wire.The cause of the constant ongoing and exposed wires is the damaged receptacle and wires.The root cause of the damaged receptacle and wire is excessive force placed on the monitor receptacle while an electrode belt was attached.No adverse event resulted from the damaged receptacle.

Event Description

A us distributor contacted zoll to report that a patient's device was constantly producing gong alerts and there were wires exposed.

• 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: 5287180
• MDR Text Key: 33749604
• Report Number: 3008642652-2015-07884
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/07/2015
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2011
• 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