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

Model Number WCD 4000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Syncope (1610); Ventricular Tachycardia (2132)

Event Date 11/24/2013

Event Type  malfunction  

Event Description

A retroactive review of patient flag files in the lifevest network identified a monitor reset following a treatment on (b)(6) 2013.A (b)(6) female patient's nurse reported that the patient presented at the hospital indicating that she was shocked and had syncopal episodes on (b)(6) 2013.The lifevest deployed gel at 13:44:17 and subsequently delivered an appropriate treatment at approximately 13:45:40 during an episode of ventricular tachycardia at 180bpm.The lifevest monitor reset following the treatment.The patient's rhythm remained in vt and then fluctuated in and out of lifevest detection.The response buttons were used to prevent further treatments from occurring.A normal rhythm was detected at 15:42:44.No further arrhythmia detections were declared.There was no death associated with the defibrillation event.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) was completed.The monitor was returned as routine maintenance and found to be fully functional.An investigation into monitors exhibiting the same issue found that the root cause for the reset is noise from the defibrillator pca high-voltage capacitors propagating on the main battery wire on the monitor c/a board.A real-time review request for a design change to address this issue was submitted to fda on (b)(4) 2015.No adverse event resulted from the pulse reset.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: katelynn mains ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4688712
• MDR Text Key: 5637059
• Report Number: 3008642652-2015-01932
• 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: Other,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• 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: 01/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2009
• 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: 29 YR