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

Model Number WCD 4000

Device Problem Leak/Splash (1354)

Patient Problem Skin Irritation (2076)

Event Date 07/21/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.Electrode belt (b)(4) was returned and evaluated at the distributor in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included download data review and incoming functional testing.During the incoming functional testing, the ecg acquisition and pulse delivery circuitry were verified.Upon evaluation, there was gel leaking from the front and rear therapy electrodes.The root cause of the gel leak was excessive force.

Event Description

A us distributor reported that the patient had developed a deep red, itchy, dry, heat-like rash under the back therapy electrodes.It was also reported that the electrode belt was leaking gel from the therapy electrodes.The patient was given a cream from her physician.After using the cream, the irritation improved.

• 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: andrew becker ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8922036
• MDR Text Key: 155246713
• Report Number: 3008642652-2019-06694
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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?: Yes
• Date Manufacturer Received: 07/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR