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

Model Number WCD 4000

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Reaction (2414)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation method: electrode belt sn (b)(4) was returned to a zoll distributor.Based on the available information from the distributor, which includes the incident file and the equipment evaluation report, there is no indication of a device malfunction contributing to the reported problem.The evaluation included downloaded data review as well as incoming functional testing of the device's ecg acquisition and pulse delivery circuitry, as recommended by zoll manufacturing.Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue (tm) defibrillation gel.

Event Description

A distributor contacted zoll to report that a patient had skin irritation under the front therapy electrode (te).The patient's physician prescribed a cream and the patient was using it.It was also reported that the patient had metal allergies and a skin condition.The current condition of the irritation is unknown.

• 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: alexander christie ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5223313
• MDR Text Key: 31184976
• Report Number: 3008642652-2015-07427
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR