MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

Model Number WCD 4000

Device Problem Cut In Material (2454)

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

Event Date 06/03/2014

Event Type  malfunction  

Event Description

A (b)(6) year old male patient contacted zoll customer support to report that the wires on his electrode belt were exposed.The patient was issued a replacement electrode belt.

Manufacturer Narrative

Device eval of electrode belt sn (b)(4) has been completed.The reported problem (damaged cable or wires exposed) was confirmed.As received, the electrode belt failed incoming testing.Upon investigation, the cable connecting the distribution node (dn) to rear therapy pad (te) was pulled from the strain relief.The cause of the test failures was the pulled dn to rear te cable.The root cause of the pulled dn to rear te cable cannot be positively identified, but is likely due to excessive force on the cable section.No adverse event resulted from the damaged belt.The patient was issued a replacement electrode belt.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: allison petzold ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4030338
• MDR Text Key: 4729687
• Report Number: 3008642652-2014-02230
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/14/2014

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?: Yes
• Date Returned to Manufacturer: 06/16/2014
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Patient Age: 70 YR