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

Model Number WCD 4000

Device Problem Cut In Material (2454)

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

Event Date 04/28/2014

Event Type  malfunction  

Event Description

The brother of a (b)(6) male patient called a zoll patient service representative to report that wires were exposed on the patient's electrode belt.The patient was issued a replacement electrode belt.

Manufacturer Narrative

Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed.The reported (exposed wires) has been confirmed.Upon investigation the cable connecting the distribution node to the rear therapy electrodes was pulled from the strain relief, damaging wires.The root cause for the strained cable could not be positively identified but was likely excessive force.No adverse event resulted from the strained cable.The patient received a replacement electrode belt.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL LIFECOR CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: zachary nelson ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 3879600
• MDR Text Key: 4461935
• Report Number: 3008642652-2014-01627
• 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: 05/26/2014

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: 05/07/2014
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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
• Patient Age: 56 YR